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FDA
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The Food and Drug Administration (FDA) recently released a Draft Guidance for Industry, in the form of Question and Answer (Qs…
FDA Expanding Role of Office of Criminal Investigations
Over the last year or two, the Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) has grown to play a…
FDA Proposes Making Product Approval Applications More Transparent
The Food and Drug Administration (FDA) is seeking public comments from interested persons on the proposed availability of…
Washington Legal Foundation Current Good Manufacturing Practice…
This week, the Washington Legal Foundation (WLF) will be hosting a webinar entitled, "Good Manufacturing Practice Deficiencies:…
FDA Building a Prescription Drug and Marketing Database
Over the last several years, we have written extensively about the potential implications that the Physician Payments Sunshine Act…
FDA to Survey Direct to Consumer Advertising and Prescribers
Earlier this year, the Office of Management and Budget (OMB) approved a request by the Food and Drug Administration (FDA) to…
FDA Five Year Plan on Risk Benefits Framework
The Food and Drug Administration (FDA) recently announced the availability of a draft 5-year plan describing the Agency’s approach…