While we are thankful for the FDA’s work on issuing bioequivalence guidance documents, we worry about the impact of the constant and sometimes significant revisions to previously issued draft or final bioequivalence guidance recommendations on the review and approval process. It seems that we are not alone! In remarks made at the November 27th FDA […]
Join former FDA Investigations Branch Director Ricki Chase –now with Lachman Consultants – as she draws on her 16 years of agency experience to bring you the latest insights into FDA inspections, interactions and expectations. Compliance 360° is hosted by Medtech Insight PODCAST LINEUP November 28, 2018 Compliance 360° Part 14: Leverage FDA Data To […]
I just read the Association for Accessible Medicines’ (AAM) White Paper entitled “Ensuring the Future of Accessible Medicines in the U.S., Avoiding Shortages & Ensuring Competition for America’s Patients” (here) that is being entered into the record at the FDA-sponsored meeting Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions held on November […]
With 5 business days and 6 reporting days until December 1st, OGD already has booked 79 full approval and 23 tentative approval for a total of 102 approval actions so far in November. This could be good news, as a trend towards more record numbers of approvals is now evident. We have had two consecutive […]
In a statement released by the FDA (here), the Agency cited warning letters to two “companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims.” The Agency noted that […]
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. […]
Every year at this time, we all ponder and are asked about what we are thankful for. It goes without saying, family, good health for all we love and peace on earth. We are all blessed in some way or another and we all have that one thing that stands out. Make your standout thing […]
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 […]
While we had underestimated approvals and slightly overestimated Tentative Approvals in our November 1 post (here) on this topic, nevertheless, OGD beat the old record of 126 for total approval actions in a month by 2. OGD fully approved 110 ANDAs and tentatively approved 18 ANDAs for a total of 128 ANDA approval actions starting […]
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 […]
