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FDA
FDA Issues Draft Guidance on Biologic License Applications
The FDA recently released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the…
AmerisourceBergen Specialty Group Pleads Guilty to Distributing Misbranded…
On September 27, 2017, AmerisourceBergen Specialty Group (ABSG), a wholly-owned subsidiary of AmerisourceBergen Corporation, one…
FDA Releases Draft Guidance for Industry: Statistical Approaches to…
The FDA announced a draft guidance for industry titled “Statistical Approaches to Evaluate Analytical Similarity”. The draft…
Gottlieb Speaks to RAPS Regulatory Conference
United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently spoke with attendees of the Regulatory…
FDA Guidances Being Issued Slower than Expected
We found an interesting Regulatory Focus story on the lack of FDA guidance documents since the start of President Trump’s tenure…
Industry Responds to Communication Guidances
In early 2017, FDA issued draft question and answer documents detailing how drug and device firms can discuss unapproved medical…
Is FDA Building its Talent Pool?
We recently reported on the Senate’s passage of the FDA Reauthorization Act (FDARA) which renews and enhances the FDA drug,…
A Murky Future for Off-label Promotion: New Leadership at the FDA Brings…
On May 11, 2017, Dr. Scott Gottlieb was sworn in as the U.S. Food and Drug Administration’s latest Commissioner. Since that time,…
FDA Considering Removing Regulatory Obstacles to Generic Competition
Mid-July 2017, the United States Food and Drug Administration held a public meeting to discuss options and steps to encourage…
FDA Issues Two Proposed Studies on Disclosures for Advertising
Last month, the FDA issued two proposed studies on disclosures for advertising: one for general advertising and another for…