Archive for June 2018

A heavily staffed FDA inspection of pharmaceutical giant Mylan’s manufacturing facility in Morgantown, West Virginia netted the company a lengthy Form 483 listing numerous deficiencies in the firm’s quality control unit. Source: Drug Industry Daily

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval or marketing authorization at its June meeting, including the EU’s first two CAR-T cell therapies. Source: Drug Industry Daily

The U.S. Supreme Court agreed to hear Merck’s appeal of a ruling allowing hundreds of failure-to-warn lawsuits against the drugmaker to proceed. Source: Drug Industry Daily

In the wake of hundreds of healthcare fraud arrests by the Justice Department last week, FDA Commissioner Scott Gottlieb promised more inspections of compounding and outsourcing facilities that distribute products without a valid medical need. Source: Drug Industry Daily

The FDA invited drugmakers to allow non-regulatory site visits of their facilities by CDER and CBER staff as part of its Quality Metrics Program. Source: Drug Industry Daily

CDER launched two new efforts to gather feedback about the use of quality metrics in modernizing drug quality systems, calling for participants in a voluntary pilot program and encouraging meeting requests. Source: Drug Industry Daily

Labeling for oncology radiopharmaceuticals must include information on the potential for genotoxicity and adverse reproductive toxicity, the FDA said in new draft guidance. Source: Drug Industry Daily

The FDA released guidance on the agency’s BsUFA II fee structure Thursday finalizing the changes introduced since BsUFA I — including that biosimilars will no longer be assessed supplemental or establishment fees and the number of program fees per year will be limited to five per company. Source: Drug Industry Daily

The FDA hit Surmasis Pharmaceutical of Des Moines, Iowa with a Form 483 after a February inspection revealed problems with laboratory records, computer systems and equipment inspections. Source: Drug Industry Daily

The “tangled web” of drug supply and payment chains benefits all the players except consumers, according to a Senate Finance Committee minority report. Source: Drug Industry Daily