It certainly seems that the world is getting smaller and this concept has been coming to the regulated industry for quite some time now. As early as 1999, the European Commission has been working diligently with the EMA and other regulatory bodies throughout the world to form Mutual Recognition Agreements (MRAs) related to inspections and to harmonize standards within the industry.
On July 9, 2019, FDA finalized the Guidance for Industry titled, Risk Evaluation and Mitigation Strategies: Modifications and Revisions. The current Guidance updates the previous Guidance with the same name that was issued on April 7, 2015. The update is more of a finalization; the portion of the draft that sets forth the submission procedures for REMS revisions and modifications.
New MaPP (Manual of Policy and Procedures) 6004.3 (here) fully outlines the internal process that FDA will go through for reviewing and recommending safety label changes (SLCs) for NDAs, BLAs, and ANDAs. It also discusses the process for FDA-mandated and -ordered label changes “when implementing section 505(o)(4) of the Federal Food,
Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 requires that on March 23, 2020, all New Drug Applications (NDAs) for biological products will be “deemed to be a license” under Section 351 of the Public Health Service Act (PHSA). In December of last year, the FDA published a final guidance as well as a Questions and Answers guidance regarding the complex logistics of this regulatory transition.
The list, published by the Office of Management and Budget, outlines a host of proposed and/or final rules the FDA “hopes” to publish, or at least consider, in 2019. Given the state of and the bent towards new or additional regulations in the current administration, this seems like an ambitious agenda for the Agency.
The full list can be found here (the FDA is included in the full Health and Human Services list).
The FDA’s recently published draft guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and other Quality-Related Considerations (here) is a significant improvement over the withdrawn 2012 guidance (i.e., Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product) that it replaced. The increased level of detail and wider breadth of topics gives a significantly better view of the information that the Agency wishes to see in a BLA for a biosimilar product.
On Friday May 10, the FDA published the much-anticipated final version of the guidance document Considerations in Demonstrating Interchangeability with a Reference Product. We did a general post here and, while recognizing the final version is similar (highly similar?) to the previous draft from January 2017, a careful review (as outlined here) found several useful and potentially significant changes in the final guidance.
The issue of the use of biosimilars and their uptake in the market has been a discussion point since the first biosimilar was approved in 2015. Today, the FDA issued a long-awaited guidance on how a firm can demonstrate interchangeability of a biosimilar to its reference licensed product. The guidance is titled Considerations in Demonstrating Interchangeability With a Reference Product (which is a bit confusing as it applies only to biosimilars) and can be found here.
The FDA released a draft guidance today titled Submitting Documents Using Real-World Data and Real‑World Evidence to FDA for Drugs and Biologics (here) that describes how the Agency will receive Real World Data (RWD) and Real World Evidence (RWE) and the potential use of each. After reading the draft guidance, it seems to me that the industry is still far away from being able to rely on RWD and RWE for use in supporting initial application approval,
In an immediately effective guidance document entitled Compliance Policy for Combination Product Postmarketing Safety Reporting (here), the FDA is announcing that it will exercise enforcement discretion for certain safety reporting requirements outlined in the Combination Product Postmarketing Safety Reporting Final Rule issued on December 20, 2016 (81 FR 92603) and codified in 21 CFR Part 4,