Dr. Woodcock Discusses the CDER Reorganization and GDUFA at GPhA Fall Technical Conference

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.

Speakers at GPhA Fall Technical Workshop Warn that Firms Best Understand GDUFA Review Penalties

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.

III to II – And So the Schedule Goes for Hydrocodone Combo Products

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.

Is There Snake Oil in Them Thar Pills?

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.

Back in the Headlines – FDA Updates Bioequivalence of Bupropion Extended-Release 300mg Tablets

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

Time to Tighten Your Belts and Pay Attention to Quality

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? 

Is Part 11 Dead? Part 1 of a series– Electronic Records

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.

The MaPP to Nowhere!

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,