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 […]
This morning I read Joe Graeden’s (The People’s Pharmacy) article titled “Can You Trust Generic Drug Quality” (here) and, as a former longtime senior official at the FDA who worked in the Office of Generic Drugs and have consulted for the industry for over twenty-five years, I had a kind of knee-jerk reaction and wanted […]
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 […]
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 […]
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 […]
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 […]
