The breakthrough therapy designation (BTD), once awarded to a drug product under development, triggers a rather intensive use of Agency resources, such as providing “early and frequent advice, conduct multidisciplinary meetings involving senior managers, and when appropriate, expedite the review of resultant marketing applications.” The program is designed to “facilitate and expedite” review of promising […]
The FDA has issued a proposed rule (here) to expand certain new conditions of use for OTC products. When an OTC product is approved through an NDA, it should have all of the necessary information in the Drug Facts section of the label so the consumer can properly select whether the product is appropriate for […]
Yesterday, the Agency expressed confidence that manufacturers of varenicline tablets containing the N‑nitroso-varenicline impurity can meet the FDA’s original acceptable intake limit of 37 ng or less per day. Their statement read: “FDA is now confident in manufacturers’ ability to supply patients with varenicline containing the N-nitroso-varenicline impurity at or below the agency’s acceptable intake limit […]
Data integrity (DI) has been a problem for as long as I remember, and my memory goes way back. The first real exposure I had to DI issues dates to the early days of Hatch-Waxman, passage of which had led to the generic drug scandal of the late 1980s. I could write a book about all […]
Today, the FDA published the final guidance titled “Bioavailability Studies Submitted in NDAs or INDs — General Considerations” (here). The final guidance comes after the FDA incorporated comments that it received on the draft of the same name issued on February 26, 2019. That 2019 draft guidance replaced the March 2014 guidance titled “Bioavailability and Bioequivalence Studies […]
The 505(b)(2) application is really a hybrid of a New Drug Application (NDA) approved under Section 505C of the FFDCA Act (the Act) and an Abbreviated New Drug Application (ANDA) which is approved under Section 505(j) of the Act. The (b)(2) pathway was a creation born out of the Hatch-Waxman Act of 1984. It permits […]
In the prepublication of the Federal Register today, the FDA asked for comments on issues related to trying to reduce the confusion on maximum daily intake (MDI) and maximum daily exposure (MDE) limits in its Inactive Ingredient Database (IID). The industry uses the IID to identify the level of inactive ingredients that may be safely […]
Yesterday, the FDA issued its final guidance on the Pre-Launch Activities Importation Requests (PLAIR), a process that permits importation of unapproved NDA, ANDA and CDER-regulated BLA products into the United States in anticipation of imminent approval. The original draft guidance was issued on July 24, 2013. The FDA says that it considered comments received on […]
As a result of the considerable number of comments received on the draft guidance Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry (here), particularly the number of those related to timing of the reports (originally slated for 2/15/22), the FDA […]
Back in November 2021, the Lachman blog brought your attention to the changes coming with the new FDA reporting requirements that were instituted under the March 2020 CARES Act (section 3112(e)) when it was reported at the AAM GRx-Biosims conference. This new law, enacted for COVID‑19 response and relief, includes “enhanced” abilities for the FDA […]
