Hot on the heels of the FDA’s revocation of the emergency use authorization (EUA) of chloroquine phosphate and hydroxychloroquine sulfate for COVID 19, the FDA issued a new release (here) describing the newly discovered drug interaction with Remdesivir and the two drugs that just had their EUA revoked. According to the release, the Agency is […]
In an FDA new release (here), the Agency announced that it was pulling its EUA saying they “determined that the legal criteria for issuing an EUA are no longer met”. The Agency took this action after a review of the current state of knowledge on the two drugs relative to their unproven efficacy and serious […]
Today, the FDA posted MaPP 5220.2 (here), which outlines a little-known process (because it so seldom happens) that describes how the Agency will go about converting an ANDA approval to a tentative approval (TA). The issue only occurs when a patent challenge is won by the innovator after the expiration of the thirty-month stay and […]
When I started reading Kurt Karst’s blog post entitled “Code Orange – The Orange Book Archives Have Arrived” this morning (here), I thought, well, the FDA must have developed an archive of all of the old Orange Books (OB) and Kurt is announcing FDA’s good deed? Wrongo, beaver breath! It was Kurt and the folks […]
The FDA issued an immediately effective guidance today titled Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency (here). This guidance (which will stay in effect until the public health emergency [PHE] is over) will provide additional flexibility for healthcare providers and distributors of record […]
I know that I have written about this issue multiple times (here and here; also search our blog for other data integrity posts) and I guess it is a holdover from my time at FDA and living through the generic drug scandal of the late 1980s, but, come on now, folks, the FDA’s bark seems […]
The FDA announced today the addition of 25 new bioequivalence (BE) recommendations and has issued revisions of 24 previous recommendations. FDA continues its efforts in getting ahead of the curve trying to issue BE recommendations for “(1) new chemical entities and (2) approved on or after October 1, 2017, at least 2 years prior to […]
Another month for FDA reviewers mostly on stay-at-home work due to the COVID-19 pandemic, and with the states beginning to open slowly, the Office of Generic Drugs (OGD) is chugging right along regarding its approval pace. OGD’s unofficial full approval actions for May of 63 is tied for second place among FY 2020 months thus […]
FDA issued three updated guidance documents that have revised recommendations and additional information on the preparation, manufacture, and temporary compounding of hand sanitizers under the COVID-19 public health emergency. The Agency provides additional guidance on the use of both active and inactive ingredients, updates permitted formulation and denaturing processes, and discusses permissible levels of impurities […]
The Federal Register (FR), in a pre-publication notice today (here), outlined the general process for the authorization and issuance of emergency use authorizations (EUAs) similar to the ones they have been issuing during the COVID-19 pandemic. The FDA is (as are other Agencies of the government) authorized to issue EUAs and are required to publish […]
