FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. have landed in the FDA’s crosshairs thanks to quality shortfalls, poor testing standards ...
The "Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century--A Risk Based Approach" initiative was ...
Drugs currently shortage FDA total 75 as of Dec. 30, down from 194 in June, mainly hospital injectables and acute care meds.
On track to define optimal dosing interval and advance manufacturing scale up of REYOBIQ for pivotal trial readiness in late ...
Roughly half a year after introducing the new regulatory pathway, the FDA has greenlit the first drug under its ultra-speedy—and controversial—Commissioner's National Priority Voucher (CNPV) pilot ...
ABC 11 Raleigh, NC on MSN
New pill form of weight-loss drug Wegovy to be manufactured in the Triangle
A popular weight loss drug made in the Triangle is now available in pill form. On Monday, pharmaceutical company Novo Nordisk ...
MedPharm’s topical drug product manufacturing facility in Durham has successfully completed an FDA inspection for commercial ...
Quality control errors during pharmaceutical manufacturing are unfortunately common occurrences. The majority (around 50%) of employees that work in pharmaceutical manufacturing tend to have duties ...
The U.S. Food and Drug Administration (FDA) on Thursday announced FDA PreCheck, a program developed in response to a recent executive order signed by President Donald Trump to encourage domestic drug ...
PARSIPPANY, N.J.--(BUSINESS WIRE)--Ferring Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) approved a state-of-the-art drug product manufacturing hub in Parsippany, NJ, for ...
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