Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
Browsing Category
FDA
FDA Offers Draft Guidance on E-Submissions of REMS Documents
The FDA recently released draft guidance describing how FDA plans to implement the requirements for the electronic submission of…
FDA Approves Sixth United States Biosimilar
Recently, the FDA announced that it approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s…
FDA Provides Guidance on Medical Devices
Recently, the FDA released two final guidances and a new draft guidance to increase the regulatory clarity around medical devices,…
Aegerion Resolves Criminal and Civil Actions
Aegerion recently finalized a $40.1 million settlement that resolves civil and criminal charges over its marketing of JUXTAPID®.…
FDA Issues Draft Guidance on Biologic License Applications
The FDA recently released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the…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FDA Releases Draft Guidance for Industry: Statistical Approaches to…
The FDA announced a draft guidance for industry titled “Statistical Approaches to Evaluate Analytical Similarity”.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…