The FDA warned a drugmaker in the Dominican Republic for significant good manufacturing practice violations including maintaining incomplete test data and faulty analytical methods. Source: Drug Industry Daily
A federal judge granted Shire’s motion to dismiss a Federal Trade Commission action against its citizen petitions relating to potential generic competitors, saying the FTC had not met a prerequisite…
The Council on Radionuclides and Radiopharmaceuticals sued HHS arguing it improperly interpreted the 2016 Medicaid rebate program final rule by applying it to radiopharmaceutical products. Source: Drug Industry Daily
FDA Commissioner Scott Gottlieb highlighted the need to improve international mail facility operations and market conversion to opioids with abuse deterrents Wednesday at a House Energy and Commerce Committee subcommittee…
The FDA issued Malladi Drugs & Pharmaceuticals a warning letter for significant good manufacturing practice failures at an active pharmaceutical ingredient facility in Tamil Nadu. Source: Drug Industry Daily
The first trial in multi-district litigation over claims the antipsychotic drug Abilify caused compulsive behavior must proceed in June, a federal judge has ruled. Source: Drug Industry Daily
A bipartisan group of members of the House Energy and Commerce Committee introduced new legislation to reform the FDA’s monograph system for over-the-counter ingredients and replace the agency’s rulemaking process…
The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts. Source: Drug…
The FDA issued the first clinical trial summary in its pilot program aimed at highlighting key information from pivotal trials of newly-approved drugs. Source: Drug Industry Daily
Five Manhattan doctors accepted kickbacks and bribes from Insys to prescribe its fentanyl products, according to the U.S. Attorney for the Southern District of New York. Source: Drug Industry Daily