European regulators are proposing a series of indirect methods for driving down prescription drug costs without stepping outside the science-focused parameters of their roles. Source: Generic Line
Industry groups are worried that a section of the proposed FDA and NIH Workforce Authorities Modernization Act would exempt biologics from adhering to U.S. Pharmacopeial standards for quality. Source: Generic…
Drugmakers submitting ANDAs for products using transdermal delivery systems are expected to demonstrate that they made “reasonable efforts” to optimize the adhesive characteristics of their patches, the FDA says. Source:…
In a case with broad implications for medical patent litigation, the U.S. Supreme Court showed little enthusiasm for lowering a strict appellate standard for enhanced damages during oral arguments Feb.…
Pay-for-delay deals don’t have to be in cash form for them to be at risk of an antitrust suit, according to a recent federal appellate panel ruling. Source: Generic Line
Notification requirements under the federal biosimilars law are getting renewed attention with two recent court filings: one, a petition to the U.S. Supreme Court, and the other an amicus brief…
Democrats and Republicans of the House Oversight Committee took executives of Valeant Pharmaceuticals and Turing Pharmaceuticals to task Feb. 4 over what members called a strategy of buying old drugs…
CDER is tightening up its protocols for companies submitting data about active pharmaceutical ingredients used in generic drugs. Source: Generic Line
European officials are pushing for greater synchronicity between the U.S. and EU regulators on generic approval processes as part of broader trade negotiations. Source: Generic Line
House members are growing impatient with the FDA over a lack of guidance on biosimilars, with several venting their frustrations during a hearing last month. Source: Generic Line