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 […]
I remember in the “old days” back in the 70’s, before most of you may have been born, Primatene Mist containing epinephrine, was a life saver as an OTC medicine for mild asthma. Why did it disappear from pharmacy shelves? Because it contained chlorofluorocarbons (CFCs) as a propellant. As you know, CFCs were banned, and […]
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. […]
The Fourth Annual Global Regulatory Affairs CMC Conference was held in Philadelphia on October 29‑30, 2018. The conference focused on successful developmental and post-market CMC operations and product lifecycle management tactics, based on better understanding of U.S. and global regulatory requirements for small molecules and biologics. Talking of life -cycle management, the current draft of […]
Late yesterday, the OGD finalized its 2018 statistical chart in its Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance which can be found here. There are some interesting figures and comparisons to previous years that are discussed below. Let’s look at refuse-to-receive (RTR) actions to start. FY 2018 saw the fewest RTRs […]
The FDA announced extended use dates for 72 lots of epinephrine autoinjectors. All of the 72 lots can be used for 2 months past the labeled expiration date, according to stability data supplied by the company and reviewed by the Agency. FDA noted in its announcement (here) that it does not expect or require the product […]
With many of the Drug Supply Chain Security Act (DSCSA) requirements coming upon the industry soon, the FDA’s issuance of the draft guidance document, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, discusses the verification process and expectations of the Agency relative to ensuring that products are legitimate under the […]
If the first half of October is any indication of the approval performance of OGD, then we are off to a good start of FY 2019. The first eleven business days of October 2018 yielded forty-three full approvals and fourteen tentative approvals (TAs), and there are still ten business days left in October. Two big […]
What does 42 minutes mean for Competitive Generic Therapies (CGT) exclusivity – apparently everything, when FDA approved another product 42 minutes before commercial marketing began for the first approved applicant. We don’t know for sure if it was 42 minutes (evidence of first commercial distribution) or actually 5 hours and three minutes (when the first […]
