Quality and Regulatory News - America
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.
Read more
Guidance on Cell Substrates Replaces 2006 Draft Guidance and 1993 Points to Consider Document
The U.S. FDA has finalized a draft guidance from September 2006 on the characterization and qualification of cell substrates and other biological materials used in the production of viral vaccines for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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more
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.
Read more on Annex 11 and on Annex 12