An FDA notice contained in the Federal Register (FR) notice prepublication pages today (here) has put the final kibosh on the use of ciprofloxacin 100mg tablets due to current evidence demonstrating that the increased resistance of Escherichia coli (E. coli) to the low strength of ciprofloxacin makes it no longer effective for treatment of acute […]
In an article published in Fierce Pharma today (here), Kevin Dunleavy pointed to a congressional letter (here), penned by Congresswoman Lisa McClain, Chairwoman, Subcommittee on Health Care and Financial Services, that questions the long lag time for the FDA and its advisory committee to come to the conclusion that phenylephrine, as an oral decongestant, does […]
On November 7, 2023, a press release from the FTC announced that “the Federal Trade Commission (FTC) challenged more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” […]
The FDA issued a guidance today entitled Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (here) announcing a 6-month period during which the FDA will not take compliance actions against a company for failing to meet the cosmetic listing and facility registration requirements. According to the FDA, the policy is designed to […]
Sidley Austin LLP filed a petition (here) requesting that FDA not grant orphan drug exclusivity to a ready-to-use version oral solution of vigabatrin. There are currently two versions of vigabatrin already approved with a number of generics available. The original approved NDA products (tablet and power for reconstitution) were granted orphan drug exclusivity (ODE), the […]
It has been a while since I posted about a food additive but I feel that this issue is important enough to blog about as it is a final step after a long debate about the safe use of BVO. Today, on the Federal Register’s (FR) pre-publication page (here), there is a proposed rule to […]
First, let’s look at September 2023 statistics (end of FY 2023), then we will comment on the full FY stats. As we reported here, September looked to be a slow month, and it was. While we missed a few full-approval actions (we reported forty-one), the OGD actually issued forty-four, and ten tentative-approval actions. Remember, the Agency […]
Once again, with October approval action postings surprisingly low, I confirmed that the FDA is still having trouble with its internal IT systems that generate this information and populate certain databases. While it does not appear to be impacting data regarding NDAs, the ANDA postings are spotty at best. The word came back from OGD […]
Yesterday, the FDA issued a draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” (here). If you can get that out of your mouth without taking a breath, I think you must be a free diver. The issue of disseminating information […]
Jim Jones was appointed Deputy Commissioner for Human Foods in August 2023. Through the leadership of FDA Commissioner Robert M. Califf, M.D., the overhaul of the FDA’s food program is getting well-deserved additional attention as it protects our food supply and dietary supplements. Under the new unified Human Foods Program (HFP) to be led by Jones, […]
