New Hampshire has joined the long list of states to take legal action against Purdue Pharma, maker of OxyContin (oxycodone), the company’s extended-release prescription opioid painkiller. Source: Drug Industry Daily
Tasked with thinking beyond the agency’s current policy proposals, the FDA created a new working group of senior staff members to develop ways to boost generic competition, according to Commissioner…
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In response to an increased demand for unit-dose repackaging of solid oral dosage form drugs, the FDA released new draft guidance that would allow extended expiration dating for repackaged unit-doses.…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sponsors will only need to report minor postapproval manufacturing changes on an annual basis, said the FDA in a new draft guidance.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
The European Medicines Agency plans to issue a “go-live” strategy for regulators, drug companies and other stakeholders in the run-up to the Nov. 22 launch of an upgraded EudraVigilance system…
Hedge fund investors are suing generics manufacturer Teva for not being forthcoming about a federal price-fixing investigation — saying the company’s false statements before the eventual reveal of a subpoena…