The story started in 1962 with the congressional passage of the Kefauver-Harris Amendments that added efficacy requirements for all new drug approvals. For those products approved for safety only during the period from 1938 to 1962, an evaluation of efficacy of those products was undertaken in the Drug Efficacy Study Implementation (DESI) program. The DESI […]
One unexpected outcome of the current global pandemic is that the world has received a crash course in basic microbiology. Ask just about anyone, anywhere in the world today, and they can tell you that diseases such as Covid 19 are caused by an organism too small to see, that can be passed person to […]
Well, June was apparently another good month for the OGD FDA work-from-home teams as the unofficial counts of the numbers show they managed 74 full approval actions and 5 tentative approval actions. The 74 full approval actions represented the highest total in a single month thus far in FY 2020, beating the next highest of […]
The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2. Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]
Last Friday (June 26, 2020), the Trump administration filed a legal brief with the U.S. Supreme Court requesting that the court find the Affordable Care Act (ACA) to be unconstitutional and, therefore, struck down in its entirety. Regardless of one’s opinion of the merits of the ACA to provide healthcare coverage for underprivileged Americans, there […]
The Lachman Blog has posted numerous writings on the issue of homeopathic drugs over the years that we have been publishing this blog. The most recent post on this topic was on June 17, 2020 (here). That post spoke about regulatory action taken against four manufacturers of homeopathic drugs in the form of Warning Letters. […]
The Agency has provided an updated list of drug products that are off-patent and have no unexpired period of market exclusivity and have no generic product approved. The revised list contains a 2-part listing and an appendix. Part 1 contains 269 targets products for “those drug products for which FDA could immediately accept an ANDA […]
OGD approval numbers have surged through June 15th as OGD has already issued 44 full approval actions and 4 tentative approval actions. 14 of those full approvals came on the 15th and 16th of June. Six of those approval actions were for Deferasirox Tablets, 90 mg, a generic of Jadenu. It appears that the block […]
Based on a news release titled, “FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic Drugs Pose Significant Risks to Patient Health and Violate Federal Law”, the Agency may be getting prepared to tackle regulation of the homeopathic drug market. In the release, the FDA announces that it issued Warning Letters to four […]
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 […]
