The FDA hit Florida stem-cell supplier RichSource Stem Cells with an untitled letter for  unapproved claims relating to its RICHGEN stem cell product. Source: Drug Industry Daily

In a move to help sponsors of insulin biosimilar applications, the FDA spelled out the data and information needed to support immunogenicity assessments for insulin biosimilars or interchangeables in a…

President Trump has signed without fanfare a continuing budget resolution that will keep the FDA funded at the 2019 level until Dec. 20. Source: Drug Industry Daily

The FDA hit two Aurobindo facilities for serious violations of good manufacturing practices discovered during inspections in October. Source: Drug Industry Daily

Iowa drug manufacturer Continental Manufacturing Chemist drew a Form 483 from the FDA for quality failures at its Madrid facility. Source: Drug Industry Daily

GlaxoSmithKline lost its bid to end multiple lawsuits against the company alleging that its anti-nausea drug Zofran (ondansetron) caused birth defects. Source: Drug Industry Daily

The FDA is recommending a second low-temperature test for determining if ranitidine products contain the probable carcinogen N-nitrosodimethylamine (NDMA). Source: Drug Industry Daily

CDER Director Janet Woodcock said an agency task force supports a new rating system designed to inform purchasers about drug facilities with higher reliability. Source: Drug Industry Daily

In a joint statement, acting FDA Commissioner Ned Sharpless and CDER Director Janet Woodcock announced that the agency is changing its approach to regulating homeopathic drug products that pose significant…

In a draft revision of an April 2011 guidance, the FDA has laid out its current thinking on when the agency may require postmarket studies or clinical trials for approved…