Based on multiple FDA inspections and observations over many years, both brand pharma and generic companies have learned how to be better prepared for an FDA inspection and what to expect from an FDA inspection. However, judging by the numerous Warning Letters that have been issued to Compounding Pharmacies in the last 2 years to […]
Most of us in the pharmaceutical industry have heard the phrase “targeted therapy”. Targeted therapies are drugs or other substances specifically designed to prevent cancer cells from dividing or destroying them directly, and are intended to target only cancer cells. While standard chemotherapy may affect all cells in the body (including healthy, non-cancerous tissue), targeted […]
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“FDA is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective (referred to as ‘the withdrawn or removed list’ or ‘the list’) (§ 216.24 (21 CFR […]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 […]
FDA has been busy putting out new bioequivalence (BE) guidance documents and revising others. Under the new provisions of GDUFA II, the Office of Generic Drugs (OGD) will set a goal of issuing 90 product-specific BE Guidances at least 2 years prior to the earliest lawful approval date (here) of an innovator product. While this […]
FDA announced the fees for the Rare Pediatric Disease Priority Voucher and the Tropical Disease Priority Review Voucher in the Federal Register (here) and (here). These vouchers can be used to obtain priority review for another NDA or biologic application (BLA), or the vouchers can be sold to another sponsor to use as they see […]
