The drug industry wants the FDA to drop plans to require drugmakers to report manufacturing stoppages that will result in shortages within five days of the stoppage occurring. If any timeline is imposed, 15 days is adequate, industry says. Read More

The European Commission (EC) is threatening to take legal action against Italy, Poland, Slovenia and Finland for failing to implement the Falsified Medicines Directive, an EU-wide anti-counterfeit initiative that has been in effect since Jan. 2, 2013. Read More

Nevada-based Green Valley Drugs, which recalled all of its sterile compounded products in April, has been warned by the FDA for a lack of sterility assurance and general quality control. Read More

The FDA has hit Wockhardt with a second “import alert,” banning drug products from its Chikalthana plant in western India — the latest in a spate of regulatory actions taken against the struggling drugmaker. Read More

OTC drugmaker AmeriDerm Laboratories has a long history of failing to test its Paterson, N.J., plant’s water supply for objectionable microorganisms, the FDA says. Read More

2013 ushered in a trifecta of new compliance requirements for drugmakers around serialization and tracking, supplier quality and imports. Read More

Poor investigations into numerous complaints of tablet odor and taste landed Dr. Reddy’s Laboratories a Form 483. Read More

Novel Laboratories failed to adequately address black specks on drug products and pieces of rubber found in a product container, according to a Form 483 given to the drugmaker. Read More

Roche subsidiary Genentech received a Form 483 from the FDA after an inspection found parts of the processing area for making active pharmaceutical ingredients (APIs) was covered with what resembled rust. Read More

China’s Food and Drug Administration (CFDA) is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More

A newly introduced House bill would legalize the personal importation of prescription drugs nationally, following a Maine law enacted in 2013 that is currently facing a legal challenge brought by the pharmaceutical industry. Read More