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The EMA says it will continue to invite patients to in-person discussions between reviewers and product sponsors — following a successful two-year pilot project involving five medicines. Read More
The European Commission has opened a formal antitrust investigation into South African manufacturer Aspen Pharma over concerns of excessive pricing of five cancer medicines. Read More
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 European Medicines Agency updated its guidance on post-authorization procedures, including recommendations for sponsors to voluntarily seek scientific advice. 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
Biosimilars consistently drive down average drug prices in markets where they are introduced, according to a report ordered by the European Commission. Read More