Update on ANDA Submissions for December
OGD partially updated its Generic Drugs Activity Report for FY 2016 this morning and it must have found a few more receipts.
DOJ to Continue Tightening the Screws in 2016
The Department of Justice (DOJ) and its federal partners are being very vocal about turning up the heat on compounders and dietary supplement manufacturers and marketers in 2016 and beyond. 2016 is guaranteed to be a record year for enforcement actions against manufacturers of these products that are not in compliance with the regulatory framework governing their manufacture and distribution.
OGD Revises Another Bioequivalence Guidance for Long-Acting Product – The Trend Continues
FDA recently released a revised draft Guidance outlining its new thinking on the bioequivalence requirements for paliperidone palmitate, representing still another BE guidance revision for a long-acting product, but this time for a long-acting parenteral suspension of this product for schizophrenia. The original draft BE Guidance document for this injectable suspension was issued in August 2011.
ANDA Applicants – WE HAVE A BINGO
December, the last month of the calendar year, may (we hope) represent the new normal in the approval of generic drugs. But there may also be signs of concern regarding submissions on the horizon. The Office of Generic Drugs (OGD) had a modern day record in December with 79 full approvals and 20 tentative approvals for a total of 99 approval actions for original ANDAs for the month.
FDA Publishes Proposed Rule to Revise the Requirements for Combination and Co-Packaged Rx and OTC Products
In what appears to be an effort for FDA to harmonize their treatment of combination or co-packaged prescription or over-the-counter drug products, the Agency has published a 70 page Federal Register Notice addressing this issue. The proposed rule notes that “[U]nder proposed § 300.53, two or more active ingredients may be combined in a fixed-combination […]
A Holiday Post Poem from The Lachman Blog Crew
Thanks for reading our blog this year, We write them with feeling and lots of cheer. With GDUFA, QbD, and OPQ to understand, Our team searched for news from throughout the regulated land. The year 2105 went by so quick, Picking the best blog topics was really the trick. We hope you have gained […]
Here’s a Good Idea – Give Congress the Authority to Override FDA Decisions – NOT!
Zachary Brennan of RAPS wrote a nice explanatory piece about a new bill introduced by Senator Ted Cruz (R-TX) and Senator Mike Lee (R-UT) called the RESULT Act, which stands for “Reciprocity Ensures Streamlined Use of Lifesaving Treatments” Act (S. 2388). In effect, the Act would permit reciprocal approvals by FDA for drugs approved in a certain list of countries. In addition, the bill would give Congress the authority to override certain non-approval decisions by FDA for drugs for life-threatening conditions and require FDA to make decisions on such drugs to treat life-threatening conditions in 30 days.
Woodcock Addresses CDER Priorities for 2016 – What’s Hot for Generics?
Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research presented to the Centers’ priorities for 2016. I thought I would concentrate on what Dr. Woodcock said about the generic program priorities and try to provide some color.
CDER New Drug Review Update 2015
FDA released a presentation by John Jenkins, M.D., Director, Office of New Drugs at CDER. The report is rather astounding and signals that the PDUFA program and the way FDA approached drug approval is not only collaborative but also thorough. One rather amazing piece of information is the first action approval rates for FY 2015. […]
Vistogard Can Be a Life Saver
The FDA approved Vistogard (uridine triacetate) as an emergency treatment for patient having severe toxic reactions or receiving an unintentional overdose of either fluorouracil or capecitabine. The treatment is a breakthrough for these patients and can be a life saver and/or permit earlier reintroduction of necessary chemotherapy.
