Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
Browsing Category
FDA
FDA Guidance Data Integrity and Compliance With CGMP
In recent years, FDA has increasingly observed current good manufacturing practice (cGMP) violations involving data integrity…
FDA: Draft Guidance – Procedures for Evaluating Appearance Issues and…
FDA released draft guidance to deal with what it describes as "appearance issues" that make advisory committee members…
Unlikely Bedfellows: SEC Penalties When Industry Fails to Disclose FDA…
In a unique case, the U.S. Securities and Exchange Commission (SEC) recently announced a significant settlement with AVEO…
Industry Expresses Concerns About FDA DTC Study
AbbVie, Eli Lilly, and Merck are all raising questions about the Food and Drug Administration's (FDA) plan to…
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Senators Send FDA Letter with Concerns Over Draft Guidance Documents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…