The FDA cited API manufacturer Syrmise of Holzminden, Germany, for eight violations including failure to investigate when a component, intermediate or API did not meet specifications. Source: Drug Industry Daily
The FDA and the NIH released a final template for NIH-funded investigators developing Phase II and III clinical trial protocols. Source: Drug Industry Daily
The FDA issued a warning letter to an API manufacturing facility in Hyderabad, India, citing adulteration, misbranding and other issues. Source: Drug Industry Daily
The FDA issued a Form 483 to drug manufacturer Amerigen for insufficient record-keeping and quality controls following a November 2016 inspection of the company’s Suzhou, China, facility. Source: Drug Industry…
Pfizer called for the invalidation of three Rituxan patents covering treatments for non-Hodgkin lymphomas last week, filing separate complaints with the PTO’s patent review board. Source: Drug Industry Daily
The U.S. Trade Representative flagged China and India on its latest priority watch list of countries with lax intellectual property protections for drugs. Source: Drug Industry Daily
Congress reached a deal late Sunday night on a comprehensive, 1,600-page bill to fund the federal government through September 30 — and give the FDA an extra $39 million. Source:…
The FDA has approved label changes for general anesthetic and sedation drugs given to children younger than 3 years old because of the possible risks to their brain development. Source:…
The FDA warned drug product manufacturer American Specialty Pharmacy over adulteration at its Dallas, Texas facility. Source: Drug Industry Daily
More than a dozen states are considering drug price transparency bills — most recently in California, where a state senate committee voted to advance legislation requiring drugmakers to disclose operating…