The European Medicines Agency adopted five product-specific guidances, effective Jan. 1, 2018, outlining requirements for establishing bioequivalence, including clinical study design. Source: Drug Industry Daily
The FDA has accepted Amicus Therapeutics’ submission of its rare disease drug for review, a reversal from its decision under the Obama administration. Source: Drug Industry Daily
The FDA needs to clearly communicate to drugmakers how the agency will use adverse event data gleaned through the expanded access use process, according to a new GAO report. Source:…
An FDA advisory committee voted to recommend that Wyeth’s Mylotarg return to the U.S. market as a treatment for CD33-positive acute myeloid leukemia in combination with daunorubicin and cytarabine. Source:…
A complaint about ineffective erectile dysfunction drugs led to an FDA inspection of a Texas-based compounder, resulting in a lengthy warning letter from the agency detailing sterility concerns. Source: Drug…
A U.S. appeals court revived a whistleblower lawsuit against Gilead Pharmaceuticals that accused the drugmaker of lying about its HIV drugs. Source: Drug Industry Daily
The FDA approved the most generic drugs during May and June that is has since it began tallying approvals, according to the agency’s latest report on the generics program —…
At a meeting on opioids abuse, FDA Commissioner Scott Gottlieb announced that the agency will expand its REMS requirements for extended-release and long-acting opioids to the manufacturers of immediate-release formulations…
A class action lawsuit claims that Beijing-based Sinovac Biotech misled shareholders and bribed regulators at the China Food and Drug Administration to expedite its drug and clinical trial applications. Source:…
The Association for Accessible Medicines filed a lawsuit against the attorney general of Maryland, hoping to block the state’s recently passed law ostensibly banning generic drug price gouging. Source: Drug…