pharmaphorum2d
The FDA’s Guidance on Labels and Cartons: yet another attack on pharmaceutical trade dress?
The US FDA is currently reviewing its pharmaceutical manufacturing Guidance, after receiving feedback from industry trade groups. What will the new Guidance mean for pharma companies, as well as ...
FDA recognizes need for immunogenicity assays in therapeutics with carriers or conjugates
A new article in the journal Nucleic Acid Therapeutics addresses the recognition by the U.S. Food and Drug Administration ...
JD Supra6d
Preparing for 2025: Key Trends in FDA Guidance Agendas
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year ...
JD Supra12d
FDA Relaxes Critical Positions on Use of Scientific Information in Off-Label Communications
On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care ...
Effective Leadership In Statistical Programming: Building Resilient And Client-Centric Teams
Leadership in statistical programming is about more than managing deliverables—it’s about inspiring teams and exceeding ...
EconoTimes11d
Trump to Meet Pharma CEOs to Discuss Drug Pricing, Tariffs, and Medicare Negotiations
U.S. President Donald Trump is set to meet with top pharmaceutical executives on Thursday, a White House official confirmed.