November-December PDA Letter
Free Articles to All PDA Members and Non-Members.
Crossover Moves: Making a Career on Both Sides of the Government/Industry Divide
In basketball, a well-executed crossover move gives the ball handler a clear path to the basket. There, she can either dish off for an assist or score an easy layup. The PDA Letter staff has identified another kind of crossover move—the career crossover. This happens when a professional with a long track record in the industry leaves to join a regulatory agency, or vice versa. When played well, this crossover opens up a clear path to professional growth and fulfillment. The PDA Letter
editors interviewed six individuals who executed this move in recent years.
ATMPs Offer Exciting Drugs, Face Age-Old GMP Challenges
The tone of the 2013 PDA Europe Advanced Therapy Medicinal Products
conference in Florence, Italy, last June, was set early with a presentation by Harald Petry, PhD, Chief Scientific Officer, uniQure, a Dutch company that just so happens to own the first EMA-approved gene therapy in the western hemisphere.
FDA Public Meeting Addressed FDASIA Supply Chain Provisions
This July, industry representatives gave feedback to U.S. FDA officials on Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA), specifically Sections 713 and 714, which pertain to standards of imported drugs and registration of commercial importers along with development of Good Importer Practices. The meeting was held at the Agency’s headquarters in Silver Spring, Md.
Read the full November December Issue (Members Only)
The PDA Letter
interviews six individuals who’ve worked on both sides of the industry/regulatory divide in our “Crossover Moves” cover story. Plus, read reports about the 2013 PDA/FDA Joint Regulatory Conference
from three members who attended the meeting. You can also view photos from the conference in this issue’s PDA Photostream.