FDA Issues Warning Letters to Three API Repackers For GMP Violations
FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk with significant violations of manufacturing quality standards.
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Kodak’s new pharmaceutical unit receives a $765m loan from the US International Development Finance Corporation, through President Trump’s Defense Production Act, to produce critical pharma components that are essential but have lapsed into chronic national shortage, as defined by the FDA.
As the AAM failed to demonstrate a “concrete or imminent” injury to its member companies, a US appeals court has rejected the agency’s challenge to the Californian law banning “pay-for-delay” deals.