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FDA
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FDA Draft Guidance on Expedited Programs for Serious Conditions – Drugs and…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…
FDA Launches Patient First Website
Last summer, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA), which included the fifth…
FDA MedWatch Safety and Adverse Event Reporting Program Expands Patient…
Earlier this month, the Food and Drug Administration (FDA) celebrated the
20th anniversary
of its
MedWatch program, which…
FDA: Delay of Online and Social Media Guidance Creates Confusion
It has been quite a while since we have written about social media and the Food and Drug Administration (FDA)—mostly because the…
FDA Expanded Access to Investigational Drugs for Treatment Use: Draft…
The Food and Drug Administration (FDA) recently released a Draft Guidance for Industry, in the form of Question and Answer (Qs…