An FDA inspection of Korean sterile OTC drug manufacturer Hanlim Pharm in January turned up multiple failures to follow procedures for preventing product contamination. Source: Drug Industry Daily
The FDA’s draft guidance on inclusion of adolescents in adult oncology clinical trials should clarify how the agency’s thinking aligns with international regulations, stakeholders said in comments on the June…
Sen. Orrin Hatch (R-Utah) and Rep. Greg Walden (R-Ore.) urged the Office of Management and Budget (OMB) to consider the potential fallout from the White House’s proposed rule that would…
The U.S. District Court for the Eastern District of Pennsylvania denied Johnson & Johnson’s motion to dismiss Pfizer’s antitrust litigation, which alleges that J&J engaged in anticompetitive practices for its…
In another twist in the worldwide recall of the contaminated blood pressure medication, valsartan, the FDA released two Form 483 reports issued to the API’s manufacturer in China after inspections…
A bipartisan group of lawmakers urged the White House to push for action to prevent, treat and ultimately eradicate tuberculosis at an upcoming United Nations meeting. Source: Drug Industry Daily
The Justice Department filed notice that it plans to intervene in four False Claims Act lawsuits accusing Indivior and Reckitt of improperly marketing the opioid anti-addiction drug Suboxone. Source: Drug…
The FDA says sponsors considering adaptive studies for early phase cancer treatments should focus on patients with no other options. Source: Drug Industry Daily
Taking aim at illicit synthetic opioid distribution, the Department of Justice is launching a Florida operation to prosecute every case of illegal distribution. Source: Drug Industry Daily
A Celltrion plant based in Incheon City, South Korea, was hit again by the FDA for violations observed during an inspection last month following a February warning letter. Source: Drug…