The FDA warned a Canadian drugmaker over GMP violations that rendered its anti-aging products adulterated. Source: Drug Industry Daily

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. Source: Drug Industry Daily

In response to an increased demand for unit-dose repackaging of solid oral dosage form drugs, the FDA released new draft guidance that would allow extended expiration dating for repackaged unit-doses.…

Biologics sponsors will only need to report minor postapproval manufacturing changes on an annual basis, said the FDA in a new draft guidance. Source: Drug Industry Daily

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…

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. Source: Drug Industry Daily