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Quality and Regulatory News - North America

Agency Draft Guidance Recommends Residual Solvents Limits in New Animal Drugs

A U.S. FDA draft guidance entitled Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision) VICH GL18(R) recommends acceptable amounts of residual solvents in new animal drugs for the safety of the target animal, as well as for the safety of human consumers in the case of those animal drugs intended for food producing animals.

The draft guidance updates a final guidance on the same topic and was prepared for veterinary use under the auspices of ICH.

Comments should be submitted by October 18.

Bill to Strengthen Manuf. Quality Standards, Enhance FDA Power

A bill has been introduced (S. 3409) that strengthens manufacturer quality standards, enhances FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and gives the FDA authority to recall potentially dangerous drugs.

TheDrug Safety and Accountability Act of 2010, sponsored by Senator Michael Bennet, D-Colorado, would provide FDA with additional recall power, as well as other enforcement options to respond appropriately to violations. The bill would provide tools, such as:

•Granting FDA the authority to assess civil penalties for violations of the Food, Drug and Cosmetic Act and to subpoena documents and witnesses; •Facilitating exchange of information between the FDA and other regulatory agencies •Protecting industry whistleblowers that wish to bring information to the FDA

These tools would allow FDA to investigate threats to drug quality and safety.

U.S. FDA Guidance Helps Applicants Submit CMC Drug Substance Information in CTD Format

A Center for Veterinary Medicine guidance providing recommendations on the chemistry, manufacturing and controls (CMC) information for drug substances that should be submitted to support original new animal drug applications and abbreviated new animal drug applications is now available.

The Agency guidance, Drug Substance Chemistry, Manufacturing, and Controls Information is structured to facilitate the preparation of applications submitted in Common Technical Document format

http://edocket.access.gpo.gov/2010/pdf/2010-19360.pdf

House Bill to Provide U.S. FDA with Recall Powers for Adulterated, Misbranded Drugs

A bill, HR 5740, introduced in the House of Representatives by Chairman Edolphus Towns (D-NY), amends the Food, Drug and Cosmetic act and gives the U.S. FDA the authority to demand a recall when there are signs that a drug has been adulterated, misbranded, or exposure to a drug may cause serious adverse health consequences or death.

Referred to the House Committee on Energy and Commerce, the bill also requires that anyone that the believes a drug is adulterated or misbranded or thinks that there is a reasonable probability that the use, consumption of or exposure to the drug will cause a threat of serious adverse health consequences or death should notify the FDA.

Four-Part MOU to Strengthen Collaborations among FDA, NIH, NTP and EPA

A four-part Memorandum of Understanding (MOU) has been signed by the U.S. FDA; the National Toxicology Program (NTP); the Environmental Protection Agency (EPA), Office of Research and Development; and the National Institutes of Health (NIH): National Institutes of Environmental Health Sciences, National Human Genome Research Institute and NIH Chemical Genomics Center.

This MOU will strengthen the existing collaborations that utilize the complementary expertise and capabilities of the parties in the research, development, validation and translation of new and innovative methods that characterize key steps in toxicity pathways.

The MOU became effective June 4, 2010.

Agency Draft Guidance on ICH Annex 14 Available for Comment

An Agency draft guidance on bacterial endotoxin testing is now available for comment. The draft guidance, entitled, Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 14: Bacterial Endotoxins Test General Chapter is available for comment until September 14.

Agency Draft Guidance on ICH Annex 13 Available for Comment

An Agency draft guidance on Bulk Density and Tapped Density of Powders is now available for comment. The draft guidance, entitled, Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 13: Bulk Density and Tapped Density of Powders General Chapter is available for comment until September 13.

Agency Guidance Helps Manufactures Develop, Conduct IVD Studies

A guidance designed to assist manufacturers in developing and conducting studies forIn Vitro Diagnostic (IVD) devices, particularly for those exempt from most of the Investigational Device Exemption regulations is now available. The guidance, In Vitro Diagnostic Device Studies – Frequently Asked Questions explains data considerations that ultimately will affect the quality of the premarket submission.

Agency Collects Information on Medical Device Reg.’s Requirements

The Agency is soliciting comments about recordkeeping requirements related to the medical devices CGMP quality system regulation via its collection of information requirement.

Comments can be submitted on the collection of information until August 23.

Draft Guidance Recommends Changes to Information Included in Annual Reports to Agency

A draft guidance that provides recommendations to holders of NDAs and ANDAs regarding the types of changes that may be reported in annual reports is now available.

Entitled, CMC Postapproval Manufacturing Changes Reportable in Annual Reports, the draft guidance describes CMC postapproval manufacturing changes that the U.S. FDA has determined will likely present minimal potential to have adverse effects on product quality and may be reported by applicants in an annual report.

The draft guidance excludes PET drug products.

Comments are due to FDA by September 23, 2012.

Agency Data Standards Plan to Allow More Efficient Review of Standardized data

A draft document, entitled, CDER Data Standards Plan Version 1.0, is now available for public comment. The U.S. FDA draft plan outlines the general approach proposed for the development of a comprehensive data standards program in CDER by identifying objectives of the program; processes that will be developed, and a set of recommended projects to begin in 2010.

The standards plan will ensure the development and successful use of data standards for all key data needed to make regulatory decisions, since currently the lack of standardized data does not allow CDER to efficiently and effectively perform review processes of items such as data submissions.

Comments are requested by September 15, 2010.

Agency’s CDER, CBER Seeks Feedback on Product Labeling Indexing Process

The U.S. FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are currently indexing certain categories of information in product labeling for use as terms to search repositories of approved prescription medical product structured product labeling. CDER and CBER have established a public docket to provide an opportunity for interested parties to share information, research and ideas on FDA’s indexing process.

Previously, the Agency has identified the pharmacologic class as a top priority for indexing of product labeling information; FDA is now announcing that medical product indications is another category of product labeling information that is a high priority.

Public Workshop on Drug Resistance, Development in Held in July

A public workshop, sponsored by the National Institute of Allergy and Infectious Diseases and the Infectious Diseases Society of America will be held on July 26-27 in Silver Spring.

The workshop will address scientific and potential research issues in antibacterial drug resistance, rapid diagnostic device development for bacterial diseases and antibacterial drug development.

New BE Study Procedures Articulated in FDA Guidance

The U.S. FDA has released a guidance entitled, Bioequivalence Recommendations for Specific Products, which describes a new process for making available recommendations on how to design product-specific bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies are able to access BE study guidance on the FDA website. The Agency believes that the use of the internet will streamline the guidance process and will provide a meaningful opportunity for the public to consider and comment on product specific BE study recommendations.

Agency to Collect Comments on General Licensing Provisions for Biologic Applications

The US FDA filed a collection of information notice on general licensing provisions for biologics license applications related to post-marketing studies status reports has been filed.

Section 130(a) of the Food and Drug Administration Modernization Act amended the Federal Food, Drug, and Cosmetic Act by adding a new provision requiring reports of postmarketing studies for approved human drugs and licensed biological products. Section 506B of the act also provides FDA with additional authority to monitor the progress of postmarketing studies and requires the Agency to make information publicly available that pertains to the status of these studies.

Comments on this collection of information should be submitted by July 9.

Agency Seeks Feedback on Methods for Co-Developing Investigational Drugs used in Combination

The U.S. FDA wants public input on how two or more novel, investigational drugs used in combination to treat a single disease or condition can be clinically evaluated. The Agency is establishing a docket to collect public comment and wants to use the information received to publish guidance for industry.

Comments should be submitted by September 7, 2010.

FDA Emergency Call Center Information Amended

The Agency has published a final rule amending their regulations to reflect changes in the contact information for the FDA’s Emergency Call Center.

The affected sections of the regulations are 21 CFR Parts 106 (Infant Formula Quality Control Procedures); 107 (Infant Formula); 312 (IND’s); and 803 (Medical Device Reporting).

The new contact numbers are 866-300-4374 (phone) and 301-847-8544 (fax). The change is effective June 11, 2010.

Genzyme Signs Consent Decree and Limits Production of Hormone, Receives Marking Approval for Unrelated Drug Product

On May 24, the U.S. FDA announced that Genzyme signed a consent decree to correct manufacturing quality violations at its Allston, Mass., manufacturing facility and has agreed to pay to the U.S. government a $175 mil. disgorgement penalty equaling the profits from the sale of products that were made at the plant. Under the consent decree of permanent injunction, the plant agreed to adhere to a strict timetable to bring it in line with the regulatory requirements of the Agency.

The regulatory and legal case began with a late 2009 FDA inspection that uncovered a number of serious GMP problems.

In the decree, Genzyme agreed to submit to a remediation plan based on recommendations by an independent expert. FDA has the right to refuse the plan if deemed inadequate. In addition, the consent decree provides a deadline for Genzyme to transfer its operations for filling drug vials from its Allston facility to other manufacturing sites or else it will have to give up profits from the sales of drugs filled at Allston after that specific date.

FDA is working with Genzyme during the company’s remediation to ensure availability of the company’s medically necessary drugs since it is the sole supplier of several enzyme replacement drugs for injection that are used to treat rare genetic disorders.

In a corporate release, Genzyme announced a day after entering the consent decree that the Agency has granted it U.S. marketing approval for Lumizyme, which is used to treat patients with late onset Pompe.

Agency Proposed Rule Would Allow CBER, CDER Directors to Approve Exceptions/Alternations to Biologics Reg

The U.S. FDA would like to amend the biologics regulations to permit the Directors of CBER and CDER, as appropriate, to approve exceptions or alternatives to the regulation for constituent materials.

FDA is taking this action due to advances in recent biological products licensed under the Public Health Service Act and to provide greater “flexibility” for the manufacturers of biologics products, as it is deemed that some provisions of the Act that make the existing regulations are “too prescriptive and unnecessarily restrictive.”

The rule provides manufacturers of licensed biological products with flexibility, as appropriate, to apply advances in science and technology as they become available without diminishing public health protections.

Comments on the proposed rule should be submitted by June 28.

The Federal Register announcement also contained an information collection provision on the proposed. Comments on the information collection requirements should be submitted by April 29, 2010.

Agency Public Meeting to Prepare the ICH Steering Committee and EWG for Tallinn Meeting

An Agency public meeting entitled “Preparation for ICH Steering Committee and Expert Working Group Meetings in Tallinn, Estonia” will be held May 5 from 2:30 to 4:30 p.m. The purpose of this meeting is to receive input from the public prior to the next Steering Committee and Expert Working Group meetings Tallinn, Estonia June 5–10, 2010.

Three Q4B Agency Guidances Available

The U.S. FDA has announced the availability of three Q4B guidances: Annex 7, Dissolution Test General Chapter; Annex 9; Tablet Friability General Chapter; and Annex 10, Polyacrylamide Gel Electrophoresis General Chapter. The guidances are intended to recognize the interchangeably between the local regional pharmacopoeias, so redundant testing can be avoided in favor of a common testing strategy in each regulatory region.

U.S. FDA Guidance to Close Gaps in Supply Chain by Identifying and Tracking Prescription Drugs

A recently released Agency guidance will help the Secretary of Health and Human Services develop standards, identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded or expired drugs.

The guidance, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages, is intended to assist with the standards and systems for identification, authentication and tracking and tracing of prescription drugs. The guidance identifies SNI for package-level identification only.

More guidances and regulations are anticipated that will implement the requirements of the U.S. FDA Amendments Act of 2007.

Agency Proposed Rule Would Allow CBER, CDER Directors to Approve Exceptions/Alternatives to Biologics Reg

The U.S. FDA would like to amend the biologics regulations to permit the Directors of CBER and CDER, as appropriate, to approve exceptions or alternatives to the regulation for constituent materials.

Comments on the proposed rule should be submitted by June 28.

The Federal Register announcement also contained an information collection provision on the proposed. Comments on the information collection requirements should be submitted by April 29, 2010.

ClassPCV 1 Found in Rotavirus Vaccine, Regulators Investigating

The rotavirus vaccine, Rotarix, that is used to guard against severe diarrhea and dehydration in infants, was found to contain components of PCV 1, a virus composed of a single strand of DNA not known to cause disease in animals or humans.

An independent U.S. academic research team discovered the virus in the vaccine when they applied a new technology for detecting viral genetic material to two lots of the Rotarix. When the researchers notified the manufacturer, GlaxoSmithKline, of their findings, the firm initiated extensive experiments to confirm the results and investigate further. The follow-up tests confirmed the presence of copies of DNA from PCV 1 in the two finished lots.

The U.S. FDA and GlaxoSmithKline are currently investigating how DNA from PCV 1 came to be present in the Rotarix. There is no evidence at this time that this finding poses a safety risk, though the FDA is temporarily suspending the use of the vaccine while gathering additional information about the situation.

The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) currently has determined that no action is necessary and the findings of the PCV 1 do not present a public health threat. However, they do acknowledge that the virus should not be present in the vaccine and that further information is needed from the manufacturer.

The CHMP Vaccine Working Party is holding meetings with the participation of the WHO and international counterparts from Canada and the United States. The next steps will be considered at the CHMP extraordinary meeting on March 25.

Read more from the U.S. FDA
Read more from the European Medicines Agency

Agency Collection of Information Notice on Product Jurisdiction Available

The U.S. FDA is allowing the public to comment on a proposed FDA collection of information notice which is related to product jurisdiction and the determination of organizational components that are assigned primary jurisdiction for premarket review and regulation of products that are comprised of any combination of drug, device or biological product.

A second purpose of the regulation is to enhance the efficiency of Agency management and operations by providing procedures for classifying and determining which Agency component is designated to have primary jurisdiction for any product where such jurisdiction is unclear or in dispute.

Comments should be submitted by April 16.

U.S. FDA to Hold Public Meeting on Reauthorization of PDUFA

By September 2012 new legislation will be required to replace the expiring Prescription Drug User Fee Act (PDUFA) which enables the Agency to continue collecting user fees for the prescription drug program. Without new legislation, the U.S. FDA will no longer be able to collect user fees to fund the human drug review process.

A meeting will be held on April 12 for the public to present its views on the reauthorization of PDUFA.

FDA Seeks Suggestions for Improved Regulatory Transparency

The U.S. FDA is requesting comments on ways it can increase transparency between the Agency and the regulated industry. Specifically, FDA is looking for comments on how they can make improvements in training and education for regulated industry about the FDA regulatory process in general and/or about specific new requirements; the guidance development process; maintaining open channels of communication with industry routinely and during crises; providing useful and timely answers to industry questions about specific regulatory issues; and communicating with sponsors during review of applications.

Comments must be submitted by April 12, 2010.

Provide CDER Staff Exposure to Drug Development Processes – Invite Them to Your Plant

CDER’s Regulatory Project Management Site Tours and Regulatory Interaction Program has been continued by the U.S. FDA. The goals of this program are to provide CDER staff first hand exposure to the industry’s drug development processes and a venue for sharing information about project management procedures (but not drug-specific information) with industry representatives.

Interested pharmaceutical companies may submit proposed agendas to the FDA by May 10.

Guidance on Cell Substrates Replaces 2006 Draft Guidance and 1993 Points to Consider Document

The U.S. FDA has finalized a draft guidance from September 2006 on the characterization and qualification of cell substrates and other biological materials used in the production of viral vaccines for infectious disease indications.

The finalized guidance provides recommendations to manufacturers of viral vaccines for the characterization and qualification of cell substrates, viral seeds and other biological materials used for the production of viral vaccines for human use. The Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications guidance replaces the information specific to viral vaccines for the prevention and treatment of infectious diseases that the Agency provided in the 1993 document entitled, Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.

Guidance Recommends Information to be Included in Applications Pertaining to Parametric Release for Sterile Products

A newly released U.S. FDA guidance, Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes, provides recommendations on information to include in applications in support of parametric release for sterile products terminally sterilized by moist heat.

Agency Collection of Information on Shipments of Non-sterile devices for Sterilization

The U.S. FDA is collecting information about the shipment of non-sterile medical devices for sterilization. Currently the Agency allows firms to manufacture and label these devices as sterile at one establishment and ship them in interstate commerce to another establishment for sterilization using an appropriate control mechanism. . This control mechanism requires the preparation of agreements and maintenance of certain associated records.

The collection of Information will provide for the Agency an estimate of the burden on the industry to comply with these requirements.

Comments are due by April 19, 2010.

Guidance to Assist Industry When Submitting Product Information

A guidance entitled, Contents of a Complete Submission for the Evaluation of Proprietary Names is now available. This guidance is intended to promote the prevention of medication errors. It will assist industry in the submission of complete product information; this will help the U.S. FDA evaluate the safety of proposed proprietary drug and biological product names by taking into account factors that can contribute to medication errors.

Collection of Information on Postmarket Surveillance Activities for Medical Devices

Through the Federal Register, the U.S. FDA has announced a collection of information relative to postmarket surveillance activities for medical devices. The notice references the appropriate sections of the regulations and provides the Agency’s estimate of the burden on the industry to comply with the reporting requirements.

If anyone desires to comment on the collection of information, comments are due by April 6, 2010.

Comments Needed For the Assessment of Abuse Potential of Drugs

The U.S. FDA has released a draft guidance entitled, Assessment of Abuse Potential of Drugs. It is intended to assist sponsors who are developing drug and other medical products with the potential for abuse that may need to be scheduled under the Controlled Substances Act.

Comments should be submitted by March 29, 2010 as FDA develops a final guidance on the subject.

Agency Guidance to Help with Mechanical Calibration of Dissolution Apparatus 1 and 2

The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP) guidance has been released by the U.S. FDA.

The guidance recommends an alternative method for manufacturers to comply with FDA’s CGMP regulations that require laboratory apparatuses to be calibrated at suitable intervals in accordance with established written specifications. It is intended to aid drug manufacturers (including ancillary testing laboratories) in calibrating USP Dissolution Apparatus 1 (basket apparatus) and 2 (paddle apparatus) to help assure that critical parameters associated with the dissolution apparatus meet certain mechanical calibration tolerances.

Agency Draft Guidance Available on the Immunogenicity Testing of Therapeutic Proteins

A U.S. FDA draft guidance entitled, Assay Development for Immunogenicity Testing of Therapeutic Proteins, is now available. It provides recommendations to facilitate industry’s development of immune assays for assessment of the immunogenicity of therapeutic proteins during clinical trials.

Comments should be submitted on the draft guidance before February 2, 2010.

Guidances Covering Annex 5, 8 published by the U.S. FDA

The U.S. FDA has published two guidances that are a part of the Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. One guidance contains information about sterility testing (Annex 8) and the other conveys information about disintegration testing (Annex 5).

The guidances convey recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provide specific information regarding the recognition. The guidances recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region.

Read more about Annex 5
Read more about Annex 8

Agency Extends Comment Period for Postmarketing Safety Report Requirements

The U.S. FDA has extended the comment period for the Agency’s proposed rule on postmarketing safety reporting requirements for combination products in response to requests for extensions.

Comments must now be submitted by January 29, 2010.

U.S. FDA Clinical Trail Workshop Registration Available

The U.S. FDA has announced a public workshop on Clinical Trial Requirements, Regulations, Compliance and Good Clinical Practices on March 3-4, 2010 at the Wyndham Orlando Resort in Orlando, Fla.

Registration should be made by February 26, 2010.

U.S. FDA Guidance on PET Drugs Published to Provide Clarity to Final Rule

A Final Rule, by the U.S. FDA, providing regulations on cGMP for Positron Emission Tomography (PET) drugs has been published. The regulations will apply to approved PET drugs. For investigational and research PET drugs, the requirements to follow CGMP may be met by complying with the GMP regulations and/or by producing PET drugs in accordance with the USP General Chapter on compounding PET radiopharmaceuticals. The regulations are effective December 12, 2011.

A guidance entitled, PET Drugs – Current Good Manufacturing Practice (CGMP) has also been published in the Federal Register to help producers of PET Drug products better understand FDA’s thinking concerning compliance with the PET cGMP regulations.

Read more on the final rule and on the guidance

U.S. FDA Wants Feedback on draft ICH Annex 11 and 12

The Federal Register has announced that comments are due by February 16 on draft ICH Q4b guidances: Annex 11 on Capillary Electropheresis and Annex 12 on Analytical Sieving.

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