FDA Commissioner Margaret Hamburg To Resign in March, Writes Farewell Letter to FDA Colleagues Read more
Biosimilars: FDA Calls For Comment on Data Needed To Show a Product is “Interchangeable”; Estimates Time Burden of Biosimilar Applications to be Same As Traditional Biologic License Applications Read more
How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD Guidance for Industry Read more
ACCME Update: Murray Kopelow Offers Recommendations For European CME Accreditation; Provides Thoughts For The Next Generations of CME Learners Read more