The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.

Please provide your email address to receive an email when new articles are posted on . The FDA has granted 510(k) clearance to a Bay Area commercial stage medical technology company for its novel ...

The Food and Drug Administration (FDA) recently issued a final rule updating the definition of the term “healthy” for use on food labels. This change aims to align with modern nutrition ...

20% of bioreactor runs at the Genzyme facility failed due to contamination or quality issues over 2.5 years. FDA identified 84 overdue deviation investigations, some exceeding 180 days ...

The US Food and Drug Administration has issued a warning letter to French drugmaker Sanofi (Euronext: SAN) following an inspection of its Massachusetts manufacturing site. The missive raises concerns ...

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a U.S. drug ingredients plant tied to its longstanding subsidiary Genzyme.

Transdermal GFR System (TGFR ... agreement with the FDA by demonstrating a P30 value of 94% while recruiting patients with a range of GFR values and skin tones. P30 is defined as the percentage ...

Transdermal GFR System (TGFR) is a first-in-kind product ... (“INNOVATE” or the “Company”) announced today that the U.S. Food and Drug Administration (FDA) has approved the MediBeacon ...

Today, clinical quality is woven into the fabric of nearly every aspect of health system operations, with leaders treating it as a core strategy to improve outcomes, reduce costs and address ...

Red Dye No. 3, or erythrosine, is a synthetic red food dye once popular in candies and cakes. The ... [+] FDA bans Red Dye No. 3 under the Delaney Clause, citing cancer risks observed in lab ...