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.

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.

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.