In a passionate presentation before a packed GPhA audience that left some teary-eyed, Dr. Uhl the Acting Director of the Office of Generic Drugs (OGD), whose nickname we learned is “Cook”, outlined her strategy for achieving the demanding goals of GDUFA on time.
Kiran Krishnan (Vice President, Regulatory Affairs, Apotex) presented an overview of the new stability requirements and the implications on the Generic Industry.
At the Generic Pharmaceutical Association’s Fall Technical Conference on October 29, 2013, speakers from the Office of Generic Drugs (OGD) provided a glimpse into the review accomplishments for the first year since GDUFA was passed, and as to how OGD will change its process to assure timely OGD review.
Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research (CDER) noted that her vision of the reorganization for the Center is to have “one voice for quality across all drug products including biotech.” She also indicated that while this has been a need of CDER for a while, she gave GDUFA credit as a major driver of this current effort.
Speaking at the Pre-Meeting Project Manager Workshop, OGD staff reminded participants of the fact that in year 1 and 2 of GDUFA, there are no real metrics, and reviewed the GDUFA goals for years 3-5 of the five year program. Along with this reminder, OGD GDUFA Implementation Team Member Christina Kirby noted that all amendment goals are incremental, meaning that pre-FDA Action Amendments results in an adjustment of goal date and post-FDA Action Letter submissions sets a new goal date.
On October 24, 2013 the FDA announced its intent to recommend to the Drug Enforcement Administration (DEA) that Hydrocodone-containing combination products be rescheduled into the more restrictive Schedule II. Such a move will make it more difficult for patients to obtain the products, as well as for healthcare practitioners to prescribe these products.
Not that it is a big surprise to current users (at least we hope not), but the FDA announced on October 23, 2013 that they were completing the phase-out of all medical inhalation products containing chlorofluorocarbons (CFCs) by December 31, 2013.
In a recent enforcement action against a dietary supplement manufacturer James G. Cole Inc. (here), the FDA is seeking a Permanent Injunction based on repeated violations of cGMPs and distribution of unapproved drugs. This type of “health fraud” dates back to the days of the traveling medicine men in their covered wagons selling dangerous concoctions of different herbs and drugs and making all kinds of wild health claims for products like Doctor Feel Good Elixir.
On October 11, 2013, the FDA made history by approving Nasacort Allergy 24H, an over-the-counter (OTC) version of the Rx Nasacort AQ (triamcinolone acetonide), a nasally inhaled glucocorticoid for allergy relief.
On October 3, 2012, the FDA announced its finding that the Impax Bupropion Extended-Release Tablets, 300mg, distributed by Teva, was found to be bio-inequivalent to the reference listed drug (RLD) Welbutrin XL 300 mg Tablets. The firms withdrew their product from the market.
A little over a year later, on October 10, 2013, FDA announced the results of the bioequivalence studies required by four additional companies, Actavis, Mylan, Par Pharmaceuticals, and Watson conducted to confirm a finding of bioequivalence of their approved 300 mg Bupropion Extended-Release Tablets. The studies submitted by Actavis, Mylan, and Par Pharmaceuticals confirmed that their products are bioequivalent to Welbutrin XL 300 mg Tablets. However, the study performed by Watson failed to confirm bioequivalence to the RLD, and the firm has agreed to voluntarily withdraw its product from the distribution chain
The Government shutdown is on everyone’s minds, but, as always, things happen that many of us in the general public don’t think of right off the bat to keep the title’s metaphor going. The shutout comes for any fee-paying application, supplement, device or other FDA regulated product that industry attempted to submit to FDA on or after October 1, 2013.
This is not the first time that the Office of Generic Drugs (OGD) has issued a guidance document that requires firms to assure that they have essential information in their original abbreviated new drug applications to permit a substantive scientific review. Remember prior to the 1992 Hatch-Waxman final rule when an ANDA could be submitted with just a bioequivalence protocol and the actual biostudy could be submitted as an amendment?
Hardly! But Part 11 (21 CFR Part 11), which applies to records in electronic form and the use of electronic signatures required by predicate rule (i.e., those records required to be signed by GMP regulations), has been scrutinized and discussed among regulators and the industry over the years, and the industry is still waiting on the final revised ruling.
For those of you who have not yet read MaPP 5200.3 (here). Responding to Industry Inquiries with Respect to Abbreviated New Drug Application in the Office of Generic Drugs, you better have your CEOs take a Valium prior to your reporting its contents. In a nutshell, it says you can call us – but only the Regulatory Project Manager (RPM) and the call must be from your single designated industry contact,
If you are a developer of apps for a mobile platform, are your apps medical devices, and if so, what requirements do you need to meet? The answer took FDA 43 pages to lay out in their new Guidance for Mobile Medical Applications, which was issued on September 25, 2013. And the answer is, well, it depends!