Topic: FDA warning letter
The White House asked the FDA to clear Avigan for COVID-19. FTC delays forced Aurobindo and Novartis to end generics deal. China's API output dropped.
Ipca Laboratories says the FDA is lifting a ban on products from two plants so it can ship hydroxychloroquine sulphate and chloroquine phosphate APls.
Biogen and Bayer deal with coronavirus rule-breakers in China. AbbVie's Kaletra fails COVID-19 study. Fosun licenses BioNTech's coronavirus vaccine.
It's never a good idea to shred documents and mislead FDA investigators during an inspection, and India's Windlas Healthcare could soon learn why.
After the FDA knocked the drugmaker for unsanitary standards at an Indian sterile products plant, Cipla got knocked again for not solving its issues.
The FDA has decided the risk of inspectors crossing paths with COVID-19 is greater than the risk to consumers of drugmakers failing FDA standards.
India curbs export of 26 active ingredients and drugs. China uses Roche's Actemra against COVID-19. Takeda nets $940 million through asset sales.
The FDA's promo police are out with their first warning letter of 2020, and it censures an ADHD drugmaker for misleading search engine marketing.
An FDA warning letter has been issued to Cipla's sterile injectables plant in Goa after inspectors found big problems with cleanliness.
An OTC maker that was once cited for selling unapproved suppositories has now been issued a warning letter for having dirty equipment.