The FDA’s Office of Prescription Drug Promotion issued an untitled letter to Pfizer for a misleading direct-to-consumer online video for its Estring (estradiol vaginal ring) treatment for moderate-to-severe painful sex…
The Federal Trade Commission is taking a victory lap after a federal judge ordered AbbVie to pay a record $448 million antitrust award over its handling of a testosterone replacement…
The FDA hit Eau Zone Huiles Et Fragrances with a Form 483 after an inspection determined the OTC manufacturer had numerous deficiencies at its Montreal, Quebec facility including cleaning, testing…
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 GMP…
The FDA issued warnings to the following facilities in Australia, Korea, the European Union and the United States for deficiencies in records, documentation, GMPs, testing and validation: Source: Drug GMP…
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…
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.…
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…
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