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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. Read More
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. Read More
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. Read More
The U.S. Trade Representative flagged China and India on its latest priority watch list of countries with lax intellectual property protections for drugs. Read More
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. Read More
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. Read More