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FDA
Bipartisan Policy Center Holds Briefing on Health Innovation
At a briefing hosted by the Bipartisan Policy Center (BPC), Senate Health, Education, Labor, and Pensions (HELP) Committee…
Senators Send FDA Letter with Concerns Over Draft Guidance Documents
Four United States senators sent a letter to United States Food and Drug Administration (FDA) Commissioner Robert Califf…
FDA Holds Public Meeting on Monograph Fees
The United States Food and Drug Administration (FDA) has announced that it will start to gather information on creating…
How the FDA Is Doing with Medical Devices and the Medical Device Industry
The FDA and the GAO both released data on the FDA's performance in medical device regulation over the last several years. This…
FDA Issues Guidance on Expanded Access to Investigational Drugs
The United States Food and Drug Administration (FDA) has recently issued guidance in response to a request in the 21st…
FDA Announces Information Collection Regarding Biosimilar Suffixes
The Food and Drug Administration (FDA) has announced an information collection seeking sponsors of past and present…
FDA ER-LA REMS Day 2 of the Drug Safety and Risk Management Advisory…
Day Two of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and…
Exploring Strage New Worlds – FDA’s 2016 Program Alignment and…
This article provides an overview of the FDA's initiative to realign programs from location-centered structures and…
FDA ER-LA REMS Day One of Meeting of the Drug Safety and Risk Management…
The Food and Drug Administration (FDA) is hosting a two-day long Joint Meeting of the Drug Safety and Risk Management…
The FDA Shield – The Medtronic Infuse Case and the Latest Tango of…
The U.S. Supreme Court will shortly decide whether it will hear a case that will have a significant impact on the life sciences…