In a pre-publication Federal Register notice issued today (here), the FDA announced a draft guidance titled Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry (here) to further promote the Agency’s knowledge and view that biosimilars and interchangeable biosimilars are really the same (although the Agency doesn’t come right […]
Today, the FDA issued twenty-six new and six revised Product Specific Guidances (PSGs) (here). PSGs provide the Agency’s current thinking on acceptable methods for demonstrating bioequivalence between the Reference Listed Drug or the Reference Standard designated by the Agency (if the RLD is no longer available) and the proposed generic product. These latest PSG additions […]
Well, we hit the nail on the head (at least for approval actions in March)! As predicted in our April 5th post (here), OGD issued 48 full approval actions and 13 tentative approval actions for a (low) total of 61 approval actions, and that is exactly what OGD is reporting in its official monthly stats […]
FDA has finalized its long-awaited Final Rule on Medical Devices; Laboratory Developed Tests (here). This Rule has been percolating within the Agency for a while and is the final step since the Proposed Rule was issued October 3, 2023. FDA explains that since “1976, the Medical Device Amendments of 1976 (the MDA) amended the FD&C […]
Today, the FDA published a Product Specific Guidance (PSG) with recommendations for establishing bioequivalence of oxymetazoline hydrochloride ophthalmic solution (here). As we have all recognized through the publication of numerous other PGSs over the last five years, the Agency is moving to BE waivers to establish sameness of the product as well as meet the […]
Section 744M of the FD&C Act (21 U.S.C. 379j-72), authorizes the FDA to assess and collect: (1) facility fees from qualifying owners of OTC monograph drug facilities and (2) fees from submitters of qualifying OTC Monograph order requests(OMORs). OMOR fee rates for Fiscal Year (FY) 2024 were published on September 12, 2023 (see blog post […]
In a press release issued yesterday (here), the FDA warned six companies about topical lidocaine products that can cause serious health effects and are also unapproved new drugs. The products are recommended for use after certain dermatological procedures “such as microdermabrasion, laser hair removal, tattooing and piercing.” These products are being marketed at concentrations above […]
The number of reserve samples required by current regulations has been a sore subject for both NDA and ANDA sponsors as well as testing facilities as the cost and storage requirements for the required reserve samples of both test and reference product was overly burdensome. Now, after twenty years of concern expressed by the industry, […]
The OGD’s approval actions for the month (at least those posted by March 5, 2024) are in line with the first four months of this fiscal year. There were 52 full approval actions and 11 tentative approval actions for a total of 63 approval actions. While we have not seen January’s official statistics yet, the […]
FDA published a conversation piece on narrow therapeutic index drugs entitled, “Setting and Implementing Standards for Narrow Therapeutic Index Drugs” (here ) to better inform health care professionals (HCP), patients, and other consumers regarding the use of and how the FDA treats narrow therapeutic index (NTI) drugs. Let’s look at what an NTI drug is […]
