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The European Medicine Agency’s revised guideline on the chemistry of active substances — outlining the information companies must provide the agency about the chemical entities used in a drug product — goes into effect this week. Read More
The China Food and Drug Administration is taking public comments on four proposed reforms, covering the review of new drug applications, the deregulation of clinical trials, postmarket surveillance and intellectual property rights. Read More
Scott Gottlieb was sworn in as the 23rd FDA commissioner May 11, with plans to face the nationwide opioid crisis, which he has called the agency’s number one challenge, and outlined his vision for a more risk-based, patient-centric organization. Read More
The European Medicines Agency published its annual report, listing 81 medicines recommended for approval in 2016, including 27 new active substances. 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
The European Medicines Agency plans to launch an improved version of its adverse event monitoring system, EudraVigilance, in November, with new methods for reporting and analyzing suspected reactions to investigational and authorized products. Read More
Fifty-two representatives and nine senators sent letters to HHS Secretary Tom Price and CMS Administrator Seema Verma, urging them to reverse current Medicare policy for the reimbursement for biosimilar products. Read More