Many thanks to the FDA for publishing several important new and revised guidances and a proposed rule related to the Biopharmaceutical industry this week. These include a finalized version of the “Deemed to be a License” Guidance for industry (here) with several important revisions and additions relative to the previously published draft,
After just over five years, the FDA is officially withdrawing its controversial proposed labeling rule for generic drugs. The advance publication notice in the Federal Register can be found (here). The proposed rule would have permitted ANDA holders to unilaterally revise its labeling via a CBE-0 supplement to include new or different safety information or warnings.
Today, the FDA made final and released a revision to a 2016 draft guidance titled Data Integrity and Compliance With Drug CGMP Questions and Answers (here). The document was revised “based on comments made to the draft as well as requests for FDA thinking on current best practices and additional examples.”
The guidance does have additional examples and clarifying language.
Well, since the first draft guidance on the “deemed approved” transition provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), we have been waiting to learn more about the specific process and for answers to a number of questions. FDA just issued a second revision of the question and answers document (here).
Congress has long been concerned that firms were not meeting their requirements for timely completion of postmarketing requirements and commitments (PMRS/PMCs) made at time of approval or post-approval in supplemental applications. In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA) and, on September 27, 2007, the President signed the legislation into law.
The FDA is proposing a rule, as announced in the Federal Register (FR) (here), to provide for relaxing the provisions of informed consent under specific circumstances. The history of the change is explained in the FR notice. The FDA notes that the Cures Act has provided it with the statutory basis to support the proposed regulation,
The Federal Register’s (FR) pre-publication page today contained an interesting proposed renewal for the collection of information for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (here). The notice states that:
Establishment registration information helps FDA identify who is manufacturing, repacking, relabeling, and salvaging drugs and where those operations are performed.
In a time that we find ourselves so busy, who has time to attend a conference? That was my initial thought, but when asked to speak at the conference, it became clear that this would be a unique opportunity to better understand the regulatory landscape while surrounded by members of India pharma and in the presence of key FDA regulators.
A quick survey of recent FDA Form 483s shows that firms are struggling to meet FDA expectations for timeliness of stability testing. During the last twelve months, the FDA has issued at least sixteen Form 483s for observations related to the timeliness of stability sample testing.
Neither the current guidance ICH Q1A(R2) “Stability Testing of New Drug Substances and Products” nor the FDA November 2003 Guidance for Industry “Q1A(R2) Stability Testing of New Drug Substances and Products” details the expectations for the timeliness of stability sample testing.
Yesterday the FDA announced the approval of a final REMS “governing the use of immediate-release opioid analgesic medications.” And the FDA did it in a big way, approving some 437 supplements for the various immediate-release opioid products. The FDA stated in its new release (here):
This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals.
The FDA has announced a proposed rule to repeal its regulation requiring any drug product that uses irradiation to be approved under an NDA or ANDA. The Notice states that “this action is part of FDA’s implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal,