Featured Pharma Online Editorial
-
FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating
4/24/2025
Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.
-
PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand
4/24/2025
Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.
-
ICH Revises Q1 Guideline, Advancing Stability Testing Standards
4/24/2025
In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
-
Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers
4/17/2025
The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts.
-
Climbing The Blockchain Ladder To Optimize Clinical Supply Forecasting
4/16/2025
Layering AI on top of blockchain technology offers a powerful way to predict kinks in the supply chain. Here's a look at where the technology is headed.
-
How AI Is A Game-Changer For Auditing Compliance And Efficiency
4/9/2025
In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.
-
Oral Therapies Take Center Stage For PsO And PsA Treatment
4/1/2025
The recent American Academy of Dermatology 2025 Annual Meeting in early March saw major updates for two key oral therapies in autoimmune diseases.
-
AI Model Cards Make Function And Risk Easier To Understand
3/31/2025
AI doesn’t follow predefined logic like traditional software. Here's a tool, including a downloadable template, to answer critical compliance questions quickly.
-
Amgen's Deep Learning Approach To Vial Inspection
3/31/2025
The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.
-
Generic Drug Approvals In Canada: Use Of A Foreign-Sourced Reference Product As A Canadian Reference Product
3/10/2025
Brush up on guidance on how to demonstrate that a foreign-sourced reference drug is acceptable to the Minister of Health as a Canadian reference product for an Abbreviated New Drug Submission and Abbreviated Extraordinary Use New Drug Submission.