GBL product maker RenewTrient Research asks FDA for proof that gamma butyrolactone presents a risk to consumers in a Feb. 11 letter to the agency. The Cocoa Beach, Fla.-based firm requests an FDA response within 30 days and, depending on the strength of the evidence against GBL, says it may return the supplement ingredient to the market. FDA has not yet responded to the letter.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.
FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
