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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

  • ORA, CDER Align on Manufacturing

    Nov 3, 2017

    The U.S. FDA continues to restructure its field activities, moving away from a geographic focus to a structure based on program-aligned commodity areas. As part of this process, CDER and the Office of Regulatory Affairs (ORA) recently began implementing a concept of operations agreement that better aligns drug review programs with facility inspections. Both field and review staff will work together as part of a team-based approach that provides a holistic overview of all elements that create risk, from drug substance to drug product to manufacturing.

    The Agency hopes this alignment will help prevent manufacturing delays due to inspection issues.

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  • FDA Looks at PACs for Biologics

    Sep 15, 2017

    In early August, the U.S. FDA released the draft guidance, CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports. This draft guidance provides recommendations to holders of biologics license applications for specified products regarding the types of minor changes that need to be documented in an annual report. In particular, the document outlines CMC controls for post-approval changes the Agency considers to have minimal adverse impact on product. Under current regulations, such minor changes must be documented in an annual report.

    Comments are due Oct. 10.

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  • Supply Chain Pilot Commenting Period Extended

    Jul 5, 2017

    The U.S. FDA has extended the commenting period relating to supply chain elements of the Drug Supply Chain Security Act (DSCSA). The Agency is requesting comments on product identifiers for product tracing, supply chain technical capabilities, and identification of system attributes needed under the DSCSA.

    Comments now close April 30, 2018.

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  • FDA Establishes Oncology CoE

    Mar 10, 2017

    The US FDA has established the Oncology Center of Excellence (OCE) and appointed Richard Pazdur, MD, as its director. The OCE is part of the FDA’s larger effort to better address the needs of cancer patients through a coordinated clinical review of drugs, biologics, and devices across the Agency’s three medical product centers.

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  • FDA, EMA Agree on Mutual Reliance

    Mar 10, 2017

    In early March, both the US FDA and EMA announced that the European Union and United States have agreed to recognize each region’s GMP inspections of pharmaceutical manufacturing facilities. This agreement follows three years of work between both agencies on the Mutual Reliance Initiative. Mutual recognition of inspections is expected to result in avoidance of duplicate inspections, reduced inspection costs, and allows regulators to better allocate resources to other regions that present greater risks.

    The European Union is expected to have completed its assessment of FDA by Nov. 1, with FDA having completed its own assessment of eight EU member states.

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  • Final Combo Product Guidance Out

    Jan 27, 2017

    In early January, the FDA released its final guidance on cGMPs for combination products. The finalized guidance addresses concerns industry had expressed regarding FDA communications related to combination products. In addition, the guidance discusses the role of the lead center and other Agency divisions responsible for cGMP issues for these types of products.

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  • Owners Responsible for Quality

    Jan 27, 2017

    The FDA released a guidance for industry on Nov. 22 describing how contract manufacturing organizations can use quality agreements to delineate their manufacturing activities to ensure compliance with current GMPs. According to this document, companies outsourcing pharmaceutical operations are responsible for the quality of the final product, not the outsourcing firm.

    Comments on the guidance are due at any time.

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  • New System for U.S. Drug Imports

    Jan 27, 2017

    Effective Dec. 29, certain data on FDAregulated products imported into the United States must be submitted through the Agency’s Automated Commercial Environment (ACE) system. This more streamlined import process is expected to result in efficient use of Agency resources and more effective enforcement of FDA regulations. ACE replaces the older Automated Commercial System. The new system offers a single window for importers, eliminating the need to submit information more than once.

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  • FDA Making Strides with MRI

    Jan 27, 2017

    The FDA recently announced that the Agency hopes to sign an agreement with the European Union soon on the Mutual Reliance Initiative (MRI). At this time, the two entities are completing assessments of drug manufacturing inspectorates for two to four EU countries. The Agency launched this initiative with the EU in 2014 to create an expanded inspectorate that enables FDA investigators and trusted EU partners to work together to avoid duplicate inspections by relying on each region’s inspection information. This would allow the United States and European Union to devote more resources to regions where drug manufacturing has greatly increased, such as China and India.

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  • President Signs 21st Century Cures Act

    Dec 13, 2016

    On Dec. 13, President Barack Obama signed the 21st Century Cures Act into law. This Act creates a new pathway for regenerative medicines, requires less use of data in bringing drugs and devices to market, and encourages adoption of continuous manufacturing through FDA-provided grants.

    The Act also provides additional funding for research on cancer and opioid addiction.

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  • FDA Releases Revised Metrics Guidance

    Nov 29, 2016

    On Nov. 23, the U.S. FDA released its revised guidance on quality metrics. This version includes comprehensive definitions for metrics categories as well as reporting tiers for various types of organizations. In addition, the document establishes an initial period where reporting of metrics will be voluntary.

    Comments are due March 27.

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  • FDA Seeks to Change GLPs

    Oct 3, 2016

    In August, the U.S. FDA proposed amending its Good Laboratory Practice (GLP) regulations to require a complete quality system approach for nonclinical laboratory studies. This approach is called a GLP Quality System and features safety and toxicity studies used to support product submissions to FDA. The Agency also seeks to revise the definition of a “testing facility” in light of current practices, such as multisite studies. This proposed revision is intended to build quality into nonclinical laboratory studies and help ensure data integrity.

    Comments are due Nov. 22.

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  • Health Canada On Track for Drug Shortage Deadline

    Oct 3, 2016

    This summer, Health Canada announced it is on track to meet requirements for reporting drug shortages via a third-party reporting site by its spring 2017 deadline. After the new reporting site is launched, it will replace the current drug shortages website. Before the new site is up, however, Health Canada expects companies to continue posting information about drug shortages and product discontinuances on the drugshortages.ca website.

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  • New Pre-RFD Process for Combo Product Submissions

    Oct 3, 2016

    The FDA plans to change its internal procedures for responding to sponsors on preliminary product classification assessments from the Office of Combination Products (OCP). This new process, the Pre-Request for Designation (Pre-RFD) process, will require sponsors to provide a detailed product description. Once OCP receives this information, the Office will make an assessment regarding product classification and Center assignment. The Agency’s goal is to respond to sponsors 60 days following receipt of all the necessary information. A draft guidance on this process is forthcoming.

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  • FDA Responds to Zika

    Aug 11, 2016

    In a blog post over the summer, the U.S. FDA announced its plans for minimizing the impact of the Zika virus by partnering with other U.S. government agencies, the private sector and the international regulatory community, including the WHO and ANVISA (the Brazilian Health Regulatory Agency) on vaccines and treatments. As of July, 120 FDA staff members are working in response to the outbreak.

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  • FDA/EMA Discussions Include MRI

    Aug 11, 2016

    Over the summer, members of the U.S. FDA met with several European Union regulatory counterparts and stakeholders in Brussels to discuss ways to strengthen their shared commitment to product safety and public health. Discussions covered global supply chain issues, globalization of drug development, and the Mutual Reliance Initiative (MRI). Toward the conclusion of the trip, FDA officials reviewed EMA’s mutual reliance plans. Both agencies expressed hope to continue regulatory alignment.

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  • FDA Opens New Oncology CoE

    Aug 11, 2016

    U.S. FDA Commissioner Robert Califf, MD, selected Richard Pazdur, MD, to become acting director of the new Oncology Center of Excellence. This Center will be a place where regulatory scientists and reviewers with oncology clinical expertise in drugs, biologics and devices will collaborate and support an integrated approach to the advancement of cancer treatment.

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  • FDA Releases Additional Compounding Guidances

    Aug 11, 2016

    On July 7, the U.S. FDA issued two draft guidances regarding compounded drug products that are “essentially a copy” of approved and commercially available drug products. Comments on both draft guidances are due Oct. 11.

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  • FDA Releases Elemental Impurities Guidance

    Jul 27, 2016

    The U.S. FDA draft guidance, Elemental Impurities in Drug Products, provides recommendations regarding the control of elemental impurities of human drug products marketed in the U.S. in order to remain consistent with the implementation of ICH Q3D. The draft guidance will also assist manufacturers of compendial drug products in responding to the issuance of the USP requirement for the control of elemental impurities.

    Comments on the this guidance are due Aug. 30.

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  • CBER Releases 2015 Annual Summary

    Jul 7, 2016

    CBER recently published its Annual Summary for 2015. This summary contains an overview of the reports CBER received during the fiscal year, including detailed information regarding the number and types of deviation reports.

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  • New Quality Metrics Conformance Guide Available

    Jul 7, 2016

    The U.S. FDA recently released its Quality Metrics Technical Conformance Guide, Version 1.0, which serves as the technical reference for the draft FDA guidance, Request for Quality Metrics. The guide provides recommendations about submission of information that will support the FDA’s calculation of quality metrics.

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  • FDA Guidance Looks at ISO Standards for Device App Evaluations

    Jul 7, 2016

    To assist industry in preparing premarket applications, humanitarian device exceptions, investigational device applications and premarket notifications, the U.S. FDA has released its Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process' guidance.

    Comments may be submitted at any time.

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  • A Case for Quality for Devices

    Jul 7, 2016
    The U.S. FDA’s Case for Quality initiative encourages open engagement between all members of the device ecosystem to enhance the quality of medical devices. This program is one of the Center for Devices and Radiological Health’s 2016-2017 strategic priorities.
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  • FDA Seeks to Strengthen Protection of Reg Filing Data

    Jul 7, 2016
    The U.S. FDA is working on strengthening its protection of pharmaceutical data submitted in regulatory filings during the approval process of new drugs. According to the Agency’s 2015-2018 Information Technology Strategic Plan, the U.S. FDA will implement independent verification and validation for high‐risk systems, move to a next‐generation network security architecture and improve the agency's patch management plan.
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  • Sci Tech Council Urges New Tech for Pharma, Biopharma

    Jul 7, 2016

    In April, the Subcommittee for Advanced Manufacturing of the National Science and Technology Council, a Cabinet-level council in the U.S. executive branch, published a report that captured technology areas in advanced manufacturing that are current priorities for the U.S federal government and are strong candidates for focused Federal investment and public-private collaboration. Emerging technology areas include advanced materials manufacturing, engineering biology to advance biomanufacturing, biomanufacturing for regenerative medicine, advanced bioproducts manufacturing and continuous manufacturing of pharmaceuticals.

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  • FDA Releases 3D Printing Guidance

    Jul 7, 2016

    The U.S. FDA draft guidance, Technical Considerations for Additive Manufactured Devices, outlines the Agency’s initial thinking on technical considerations specific to medical devices using additive manufacturing (AM), the broad category of manufacturing encompassing 3-dimensional (3D) printing. The draft guidance outlines technical considerations associated with AM processes and recommendations for testing and characterization for devices that include at least one AM fabrication step. This draft guidance is a “leap-frog guidance,” intended to serve as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development.

    Comments on this document should be submitted by Aug. 8.

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  • FDA Remains Committed to EvGen

    Jul 7, 2016

    The U.S. FDA continues to develop EvGen, its national system for evidence generation. In practice, EvGen would be an umbrella for all activities that help inform all stakeholders about making treatment decisions. The platform is built on the concepts of interoperability and connectivity—essential prerequisites for the creation of a successful national system for evidence generation.

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  • CDER Launches New Online Export Tracking System

    Jul 7, 2016

    In Q2, CDER launched its new electronic CDER Export Certification and Tracking System. The system allows users to request a CDER Certificate of a Pharmaceutical Product (CPP) online as an alternative to a paper submission. The new software provides many features; including reducing the amount of time it takes to process a certificate, a step-by-step guide to applying for a CPP, real-time validation of data submitted and email notifications regarding the status of a CPP request.

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  • New Prep and Potency Limits for for Biologics Sought

    May 12, 2016

    The U.S. FDA proposes to amend standards for biologics that pertain to preparations and limits to potency due to the availability of new technology and testing capabilities.

    Comments on this proposed rule are due July 18.

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  • FDA Releases 3D Printing Guidance for Device Manufacturers

    May 12, 2016

    The U.S. FDA recently released a draft guidance outlining technical considerations for device manufacturers using 3D printing.

    Comments are due Aug. 8.

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  • FDA Makes Recommendations on Immune Assays for Clinical Trials

    May 12, 2016

    The U.S. FDA has released the draft guidance, Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products. This draft guidance provides recommendations regarding development and validation of immune assays for assessment of the immunogenicity of therapeutic protein products during clinical trials.

    Comments are due June 24.

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  • CDER Launches Export Tracking System

    May 12, 2016

    CDER launched its new electronic CDER Export Certification and Tracking System. The system allows users to request a CDER Certificate of a Pharmaceutical Product (CPP) online as an alternative to a paper submission. The new software provides many features; including reducing the amount of time it takes to process a certificate, a step-by-step guide to applying for a CPP, real-time validation of data submitted and email notifications regarding the status of a CPP request.

    Continue reading »
  • FDA Continues to Look at Compounding

    May 12, 2016

    The U.S. FDA continues to respond to concerns about pharmaceutical compounding with the release of three additional guidances on April 15. These guidances cover prescription requirements, regulation of compounding in state-licensed hospital or health system pharmacies and facility definitions.

    Comments on all three are due by July 18.

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  • U.S. FDA, Provincial Chinese FDAs Strengthen Cooperation

    May 5, 2016

    Staff from the FDA’s China Office recently met with provincial FDA regulators, industry and academia in China’s Yangtze River Delta region to discuss strengthening partnerships, sharing information and building the foundation for future cooperative engagement.

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  • FDA Releases Data Integrity Guidance

    May 5, 2016

    The U.S. FDA recently released a long-awaited draft guidance on data integrity and compliance with cGMPs. This document clarifies the role of data integrity in cGMPs.

    Comments are due June 14.

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  • Second U.S. Biosimilar Approved

    May 5, 2016

    On Apr. 5, the U.S. FDA approved a second biosimilar product, Inflectra (infliximab-dyyb), which is administered by intravenous infusion to treat Crohn’s disease, ulcerative colitis and moderate to severe rheumatoid arthritis. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab).

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  • FDA Establishes Combo Product Policy Council

    May 5, 2016

    The U.S. FDA recently established the Agency’s first Combination Products Policy Council. This Council will serve as communications hub for discussing, resolving and implementing product and policy issues related to combination products. In addition, the Council will play an integral role in the development of internal and external communications such as draft guidances, publications and blog posts regarding policy decisions.

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  • FDA to Develop Device Evaluation System

    May 5, 2016

    The U.S. FDA is building the foundations of a national medical device evaluation system to generate better evidence more efficiently for medical device evaluation and regulatory decision making. The collaborative national evaluation system, one of CDHR’s 2016–2017 strategic priorities, will link and synthesize data from different sources across the medical device landscape and improve the quality of real-world evidence that healthcare providers and patients can use to make better informed treatment decisions.

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  • FDA Approves Change to Continuous Manufacturing

    Apr 14, 2016

    On April 8, for the first time, the U.S. FDA approved a manufacturer’s change from batch to continuous manufacturing. This was for Janssen Product’s HIV-1 medication, Prezista. The company relied on a recently released FDA draft guidance to support the change.

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  • FDA Looks to Lean Management for Combo Products

    Apr 1, 2016

    In order to improve the overall efficiency, consistency and predictability of combination product review, the U.S. FDA is developing a lean management process mapping approach, which includes an analysis of current processes to highlight existing sources of delay or redundancy, and creation of a “future state” map that identifies a streamlined process that addresses the previously identified delays and redundancies.

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  • ORA Ombudsman Takes Office

    Mar 10, 2016

    Jessica Zeller is the new ombudsman in the U.S. FDA’s Office of Regulatory Affairs. Her responsibility is to resolve, when possible, problems between the Agency and external partners.

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  • CDRH Lists 2016 Guidance Documents

    Mar 10, 2016

    CDRH has released its list of guidance documents for 2016. The documents listed fall under three categories: "A-list" documents the Center fully intends to publish, "B-list" documents to be published as resources permit, and final guidance documents issued in 2006, 1996, 1986 and 1976 subject to retrospective review.

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  • FDA Seeks Human Factors Data

    Mar 10, 2016

    The FDA has issued a draft guidance that lists which devices medical device manufacturers must have human factors data included in their premarket submissions. The Agency believes that inclusion of this data will help it evaluate the potential for use errors in these devices.

    Comments are due May 3.

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  • CBER Releases 2016 Guidance Doc List

    Feb 29, 2016

    CBER has released the list of guidance documents the Center plans to publish in 2016. Documents of particular interest include early clinical trials with live biotherapeutic products and recommendations for screening donors for Zika in cell, tissue and gene therapy products.

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  • U.S. Senate Confirms FDA Commissioner

    Feb 25, 2016

    On Feb. 24, the U.S. Senate confirmed Robert Califf, MD, as commissioner of the U.S. FDA. He is currently Vice Chancellor of Clinical and Translational Research at Duke University. His background is in cardiology.

    Califf replaces Margaret Hamburg, who stepped down last year. Stephen Ostroff has been serving as interim commissioner.

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  • FDA to Delay Some UDI Requirements

    Feb 24, 2016

    On Feb. 3, the U.S. FDA released the draft guidance, Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices. This guidance will outline FDA’s plan to not enforce the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages, with respect to certain finished devices manufactured and labeled prior to Sept. 24, 2018 before Sept. 21, 2021.FDA realizes developers need additional time to ensure that unique device identifiers (UDIs) do not include NHRIC or NDC numbers and does not wish to disrupt the supply chain.

    Comments due April 4.

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  • FDA Looking at Device Usability

    Feb 15, 2016

    The U.S. FDA recently issued a guidance on applying human factors and usability engineering to medical device due to concerns that user interfaces are designed to minimize or eliminate the risk of errors.

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  • FDA Continues to Tackle New Tech

    Feb 10, 2016

    The U.S. FDA continues to take steps toward encouraging modernization of pharmaceutical manufacturing, including establishment of the Emerging Technology Team and a recent draft guidance.

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  • Interconnected Devices Need Special Considerations

    Feb 2, 2016

    Medical devices are becoming ever more interconnected with not just other devices but other forms of technology as well. For this reason, on Jan. 26, the U.S. FDA released the draft guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices. This document outlines the Agency's "specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information," and includes considerations that should be included in the development and design processes for these interconnected devices.

    Comments are due March 28.

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  • 2016 CDER Guidances Cover Wealth of Issues

    Feb 1, 2016

    CDER has released its list of planned guidances for 2016. These include guidances concerning statistical approaches to support a demonstration of biosimilarity, combination products that utilize software, CMC post-approval change documentation and more.

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