Category: News
-
The ANDA Prioritization Pilot Is a Smart, Strategic Move to Rebuild U.S. Generic Drug Manufacturing Capacity
The Food and Drug Administration’s new ANDA Prioritization Pilot realigns regulatory incentives to reward onshore bioequivalence testing and U.S. manufacturing of finished dosage forms and active pharmaceutical ingredients (API), and it will strengthen supply‑chain resilience, lower inspection costs, and speed patient access to affordable generics. The policy leverages FDA review speed as a targeted market
-
Acetaminophen Use During Pregnancy Has No Credible Link to Autism
Acetaminophen, widely recognized under the brand name Tylenol®, is the most commonly recommended over-the-counter (OTC) analgesic and antipyretic for pregnant women. For decades, both regulatory agencies and medical professionals have considered it the safest option for managing pain and fever during pregnancy, especially given the well-documented risks associated with alternatives such as NSAIDs and opioids.