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 […]
The FDA is warning about a serious and potentially fatal adverse event that has been reported with use of the antiseizure medications levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan). The ADE, called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), is extremely rare and the “FDA’s cumulative review found 42 serious […]
Not sure what is taking the FDA so long to fix the system “glitch” in reporting ANDA approval actions, but this has been going on for quite a while. Here we are, the day before Thanksgiving, and there are only 14 full ANDA approval actions and 9 tentative approval actions listed in the available FDA […]
Bring up the recently updated and finalized EU Annex 1 – Manufacture of Sterile Medicinal Drug Products (here) in polite pharmaceutical water cooler conversation and a frequent topic that comes up is the Contamination Control Strategy (CCS) language. Buzzwords abound for a “holistic”, “global”, or “wholesale” CCS to be incorporated into all elements of aseptic […]
Just like the FDA says on its warnings and notifications page (here): “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers. FDA cannot test all products on the market that contain […]
I am sure that any of you that have listened to radio or watched TV have heard a prescription drug ad and have struggled with keeping up with the fast talking and not so slow walking people, scene, or scrolling of text on direct-to-consumer ads. FDA has been working to develop standards over the course […]
This has been a tough year for pharmaceutical companies, with price concerns on the tip of everyone’s tongue, the race to the bottom on generic drug pricing and its impact on drug shortages, FDA now back almost fully in the facility inspection mode, Warning Letters flying out of the Agency at a breakneck pace, and […]
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,” […]
Earlier this year, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry.” The proposed Guidance uses a risk-based approach based on product quality or facility-related risks and will be determined on a case-by-case basis by the FDA. Are you among the many […]
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 […]
