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FDA
Despite Critics Dismissal – Off Label Prescribing May Benefit…
Over the past several years, the federal government and law enforcement agencies have increasingly investigated and prosecuted…
FDA: The Growing Use of Freedom of Information Act Requests for FDA Data by…
The Wall Street Journal reported on the use of FOIA (Freedom of Information Act) requests by investment firms with the intent to…
FDLI 2013: Insights in Enforcement, Litigation & Compliance for…
The Food and Drug Law Institute (FDLI) recently held its annual Advertising & Promotion Conference, which included in-depth…
FDA-EMA Meeting on Orphan Drug Development: Offers Overview of Program and…
The Food and Drug Administration (FDA) recently announced its Office of Orphan Products Development will be holding a meeting…
FDA: If the Government Shuts Down Tonight – Now What?
If the government shuts down tonight, Alexander Gaffney, News Editor at Regulatory Focus notes: "regulatory professionals are…
FDA and Social Media Do’s and Don’ts Based on Warning Letters, Waiting for…
The Food and Drug Law Institute (FDLI) recently held its annual Advertising & Promotion Conference, which included in-depth…
FDA: Trends in Enforcement Letters from the Office of Prescription Drug…
During the recent Food and Drug Law Institute's (FDLI) Advertising & Promotion Conference, Julie K Tibbets, a Partner at…
FDA: Draft Guidance on CDRH Appeals Process
On the FDA Voice Blog, David S. Buckles, PhD, FACC, and Lawrence "Jake" Romanell, from the FDA's Center for Devices and…
Staff Changes at the FDA’s Office of Regulatory Affairs: New Regulators and…
On September 3, 2013, FDA Commissioner Margaret Hamburg, M.D. announced in an email to FDA staffers that Melinda Plaisier would…
FDA Primer on Drug Development for Patient Organizations
The Food and Drug Administration (FDA) recently announced a meeting for patients, caregivers, patient advocates, as well as…