The FDA has backed away and revoked a number of Emergency Use Authorizations (EUAs) that it had issued in the past, including those for hydroxychloroquine and a multitude of less-than-accurate COVID‑19 tests. By all accounts, there is a degree of trepidation in the scientific community that many of the Agency’s decisions regarding EUAs are being […]
Clearly, the FDA has acted too early on Emergency Use Authorizations (EUAs) for a few COVID-19 tests and products. The flurry of revocations of EUAs for tests that were deemed not reliable have cause a sputter in the onset of testing ramp up. Another specific example was the FDA’s EUA for hydroxychloroquine, which left many […]
There has been a lot of discussion about the need to retain up to five times the amount of test and reference drug product to perform release testing as reserve samples for products used in in vivo or in vitro bioavailability (BA) or bioequivalence (BE) testing for NDA or ANDAs products. The requirements were at […]
OGD reported 69 full approval actions, which we hit on the head, (three of the full approvals were for first time generic approvals) and 13 tentative approval actions (we reported only 9, as that was all that was found on the FDA’s All Approvals site at the time) for a total of 82 approval actions […]
FDA finalized its guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff” (quite a mouthful) today (here) which was originally issued as a draft in September 2018. The FR Notice announcing the availability of the guidance (here) indicates […]
How has COVID 19 changed your organization? Do you have fewer or newer employees? Have you kept up with training requirements, or has your focus been more targeted towards keeping the freight moving? Has your workforce stabilized with sufficient personnel to perform the complex cGMP tasks necessary and the documentation requirements expected by the FDA? […]
As of August 5, 2020, the FDA had posted 69 full approval actions and 9 tentative approval actions for ANDAs for July 2020. The total of 78 approval actions for the month of July fall short of the 87 Approval actions in June but appears to be consistent with the last four month’s totals. Some […]
A look at the pharma industry’s concerted effort to develop vaccines against the SARS-CoV-2 virus and therapeutics to treat COVID-19. Contract Pharma recently published an article authored by Keith O. Webber, Lachman Consultants. He says, “Although we are faced with significant challenges, hopefully the recently published guidance documents from the FDA in conjunction with the […]
Today, the announcement of the User Fees for three FDA programs today were published in the Federal Register notice prepublication. PDUFA, animal and generic drug fees and medical device fees for FY 2021 start October 1, 2020 and are provided below. We await the GDUFA fee announcement, which we should see in a day or […]
Outsourcing facilities are compounding facilities defined under section 503B of the Federal Food Drug and Cosmetic Act (FD&C Act). There are yearly fees associated with establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the FD&C Act. The FDA has Just published the fees for […]
