The FDA notes that many of the emergency use authorization (EUA) tests currently being utilized are subject to false-negative results. The FDA emphasizes (here) that variants seen in the virus may have a significant impact on COVID-19 tests and this will likely occur with greater frequency, especially as some of the variants become predominant in […]
Yesterday, the FDA issued a guidance document titled Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers (here). The guidance covers three broad areas: Generic drug product development ANDA submission and assessment and Marketing and exclusivity. The guidance offers many hints on how the Agency may deal with issues that […]
We previously intimated (here) that March came in like a lion but might go out like a lamb; however, thanks to a flurry of approval actions in the last four days of the month, it looks like the lion might have stayed in the approval picture for most of the month. The unofficial number of […]
Well, a little late this month, but OGD posted the first wave of its February 2021 metrics. The Agency issued 72 Approval actions and 7 tentative approval actions (we reported 72 and 6 respectively (here -looks like they snuck in a late TA). So, a total of 79 total approval actions in February, which just […]
The FDA has released its most current list of Competitive Generic Therapy (CGT) ANDA approvals (here). CGT-designated products (products for which there is little, if any, generic approvals for NDA products) may be eligible to receive 180-days of market exclusivity from a subsequent ANDA approval for the same strength and product. After any ANDA approval […]
In a podcast, FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm (here). The warning first came from FDA on March 25, 2021 in the form of a drug safety communication (here). The product marketed as Benzedrex is safe and effective when used in accordance with its […]
A Federal Register notice published on March 26, 2021 announced the Over-the-Counter (OTC) Monograph User Fee rates for the Agency’s newest UFA, OMUFA, 2021. There are two types of user fees; one is for facilities of firms that manufacture and distribute OTC products (monograph drug facilities (MDFs)) and the other is for a subset of […]
March came in like a lion and looks to be going out like a lamb. With seven reporting days left, we counted forty-nine approval actions and four tentative approval actions for the OGD. These numbers are tempered a bit by the fact that (as we have mentioned previously) the OGD reports every action it takes […]
The FDA reviewed five (5) bulk drug substances for inclusion in the bulk APIs that can be used by outsourcing facilities in the compounding of drug products. The five (5) nominated for consideration were: quinacrine HCl, bromfenac sodium, mitomycin–C, nepafenac, and hydroxychloroquine sulfate. Only quinacrine HCL for compounding for oral products for the treatment of […]
For those of you that are not directly in the pharmaceutical industry or who are not healthcare providers, you may wonder why the FDA is having a meeting to discuss the morphine milligram equivalents for other opioids. Well, I know that measure gives healthcare providers a good idea of how to transition patients taking morphine […]
