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The FDA has released a public notification advising consumers not to purchase or use a weight loss and energy supplement called Natural Eruption. Read More
To shed light on the regulatory requirements for the development of co-crystals, the FDA is offering drugmakers submitting ANDAs and NDAs a clearer definition of co-crystals that no longer denotes them as an in-process material. Read More
Almost a year after Bayer settled pay-for-delay allegations involving its antibiotic Cipro, Allergan and Sanofi units have struck deals to resolve lingering Cipro claims in ongoing class action litigation, agreeing to pony up $100 million. Read More
Industry is praising the FDA for tackling both hiring and retention in its proposed goals for the next PDUFA, touting the proposals as necessary to support the agency’s initiatives. Read More