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The European Medicine Agency’s safety committee is recommending labeling changes for several products to cover newly identified risks of adverse events and side effects. Read More
In response to an increased demand for unit-dose repackaging of solid oral dosage form drugs, the FDA released new draft guidance that would allow extended expiration dating for repackaged unit-doses. Read More
Biologics sponsors will only need to report minor postapproval manufacturing changes on an annual basis, said the FDA in a new draft guidance. Read More
The Drug Enforcement Administration is proposing to lower its annual manufacturing limits on certain controlled substances for 2018 — which would cut back production of several classes of opioid painkillers and other scheduled pharmaceuticals, some between 10 and 25 percent. Read More
The development of a vaccine to treat addiction represents an “incredibly exciting” initiative in the nationwide fight against opioid abuse, HHS Secretary Tom Price said Tuesday. Read More
Under the decree, Isomeric Pharmacy Solutions is prohibited from storing, processing, manufacturing or distributing drugs until it complies with FDA regulations. Read More