Generics

21
Nov

OGD Serious About Its Revised Communication Practices

While Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER) and Dr. Kathleen Uhl, Acting Director, Office of Generic Drugs (OGD) are kicking around ideas about early communications of deficiencies and potential approvals to firms, the message that OGD is clamping down on phone calls and emails is being heard by Industry loud and clear.

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11
Nov

Emergency! Emergency! Everyone to Get from Street

I am stealing a quintessential line from the movie “The Russians Are Coming, The Russians Are Coming”, to explain the emergent nature of the FDA’s proposed revision to its labeling rule to permit unilateral changes in safety information for certain applications for which the Federal Food Drug and Cosmetic Act (FDCA) clearly precludes such changes. So those of you in industry you have a choice – either raise your voices and raise them loudly, or contact your liability carriers and raise your limits and secure good defense counsel.

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08
Nov

First Look at the New OGD Super Office

Speaking at the GPhA Fall Technical Workshop on October 30, 2013, Dr. Kathleen Uhl, Acting Director of the Office of Generic Drugs (OGD) provided a first look at the structure of the new OGD Super Office. There are a number of new organizational blocks that signal to this old former OGDer that not only more changes are on the way, but that emphasis on certain pre- and post-approval issues are going to be beefed up considerably.

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29
Oct

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.

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28
Oct

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.

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