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FDA
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FDA: Draft Guidance on CDRH Appeals Process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…
FDA: Guidance Safety Labeling Changes
Recently, the Food and Drug Administration (FDA) released a Guidance for Industry: "Safety Labeling Changes —Implementation of…
FDA REMS Open Public Meeting Explored Need for Flexibility in REMS Programs
The Food and Drug Administration (FDA) held a meeting on July 25th and 26th, 2013, to discuss Risk Evaluation and Mitigation…
FDA Patient Focused Drug Development
Richard M. Klein, Director of the Patient Liaison Program in FDA's Office of Health and Constituent Affairs, recently wrote at FDA…
FDA Soliciting Input on Global Supply Chain Provisions in FDASIA
In a recent post from the FDA Voice Blog, Office of Compliance Director for FDA's Center for Drug Evaluation and Research (CDER)…
FDA Draft Guidance on Expedited Programs for Serious Conditions – Drugs and…
Recently, the Food and Drug Administration (FDA) released a Guidance for Industry, entitled "Expedited Programs for Serious…
FDA REMS: FDA Hosting a Two Day Meeting on Issues and Challenges with REMS…
Over the past year, we have written several times about the Food and Drug Administration's (FDA) goals to standardize Risk…