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 […]
Once an approved NDA product is discontinued from marketing or withdrawn, the FDA must make a determination that the reason for such action by the innovator was not for safety or efficacy reasons (see 21 CFR 314.161(a)). Such a determination must be made before an ANDA for a duplicate of the reference listed drug (RLD) […]
As we all know, the pandemic has wreaked havoc with inspections of drug manufacturers, API manufacturers, and laboratory facilities, as well as inspection of clinical study sites. Remote working, meeting problems, and just general pandemic fatigue has hindered some of the FDA’s work. However, the statistics are not as bad as one might think, all […]
(Westbury, NY – March 16, 2021) Fran Zipp, President and CEO of Lachman Consultants, Inc., a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, today announced that John McShane has joined the firm as Vice President of Cell & Gene Therapy, Compliance and Business Development. In this role, McShane […]
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 […]
With the number of emergency use authorizations (EUAs) for drugs, devices, and biologics numbering in the hundreds and the relaxed enforcement policy on certain OTC products, the Agency will have a lot to do once the pandemic is over. FDA will need to decide whether to grant final clearance or approval to a ton of […]
