There is no doubt that the Office of Generic Drugs (OGD) is receiving more work than it anticipated under the negotiated GDUFA I program. Dr. Kathleen (Cook) Uhl, Director OGD, noted that OGD received over 5 years of work in the first 4 years of GDUFA I, noting that the Agency anticipated receiving only about […]
This blog post was coauthored by Kurt Karst, Director, Hyman, Phelps and McNamara If there’s something strange in your neighborhood; Who you gonna call? If there’s something weird, and it don’t look good; Who you gonna call? Unfortunately, FDA doesn’t have a Ghostbusters-type unit to call when there’s something strange or weird compliance-wise going on […]
We asked around about what issues were driving firms crazy and these same three issues surfaced most often: 1) getting resolution of compliance status after inspection or re-inspection; 2) getting a straight answer from the Agency; and 3) what to do about maximum daily exposure issues relative to the Inactive Ingredient Database (IID). Taking each […]
Yesterday, FDA published two separate Federal Register Notices (here and here) announcing a Notice of Opportunity for Hearing (NOOH) for the withdrawal from marketing of two firms’ methylphenidate extended-release tablets. The Agency had previously expressed concerns regarding the Therapeutic Equivalence (TE) of these two products based on significantly higher reports of therapeutic failure later in […]
OGD’s final numbers for approvals and receipts and a few other metrics for the full FY 2016 were released today. OGD approved 51 ANDAs in September for a total of 651 for FY 2016, an average of 54.25 ANDA a month. This represents the largest number of approvals in a fiscal year in (at least […]
Thirty-six years ago as a young Pharmacy post-graduate, I was introduced to the “Continuous Process”. Merck commissioned the plant housing this process in the late 1970’s in the Shenandoah Valley of Virginia. Building on the company’s experience with continuous chemical processing, the plant manufactured a blockbuster (at the time) anti-hypertensive “Aldomet”, Methyldopa Tablets, USP. At […]
“FDA is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective (referred to as ‘the withdrawn or removed list’ or ‘the list’) (§ 216.24 (21 CFR […]
The FDA pre-published a Final Rule (here) today implementing Title XI of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003. FDA has been regulating directly from the statute since 2003 and now (based on various court decisions and FDA’s experience) has finalized implementing regulations for portions of the Act some 13 years […]
FDA has just updated the Activities Report of the Generic Drug Program with additional data from August 2016. FDA notes that it Refused-to-File 17 ANDAs in August, which is slightly below the average of 21/month so far this Fiscal Year (FY). OGD issued 167 Complete Response Letters (CRL) in August, above the monthly average of […]
According to a posting yesterday (here), the Office of Generic Drugs (OGD) approved 61 first-time generic products so far in 2016, with another quarter to go. When we look at the first approvals, there were multiple approvals for 10 products (so it appears that 51 different entities were approved (some of which may have been […]
