FDA releases resources for animal drug sponsors

FDA releases resources for animal drug sponsors

The U.S. Food & Drug Administration is making publicly available on its website two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications (NADAs) and related submissions. According to FDA, the changes take effect Oct. 1, 2018, as part of the Animal […]

Boston Scientific's drug-coated stent gets FDA approval

Boston Scientific's drug-coated stent gets FDA approval

(Reuters) – The U.S. Food and Drug Administration on Monday approved Boston Scientific Corp’s drug-coated stent Eluvia to treat narrowed arteries in the leg. The medical device maker intends to launch Eluvia in the fourth quarter, Jeff Mirviss, president of Boston Scientific’s Peripheral Interventions division, told Reuters. Eluvia, approved in Europe since 2016, targets the […]

Flea, tick pills can cause nerve reactions in pets, FDA warns

Flea, tick pills can cause nerve reactions in pets, FDA warns

Breaking News Emails Get breaking news alerts and special reports. The news and stories that matter, delivered weekday mornings. SUBSCRIBE Pills or chews that protect dogs and cats against fleas can cause neurological problems such as stumbling or seizures, and pet owners need more warning, the Food and Drug Administration said Thursday. The FDA issued […]

FDA opioid safety program fails

FDA opioid safety program fails

The Food and Drug Administration knew for years rogue doctors were wrongly prescribing the most potent opioids on the market by subverting the agency’s oversight program. Yet the FDA accepted the word of pharmaceutical companies administering the program that they were policing the doctors. But they weren’t, and patients died. More than 4,000 documents, obtained […]

FDA links neurological problems in pets to flea, tick drugs

FDA links neurological problems in pets to flea, tick drugs

These include Bravecto, Credelio, Nexgard and Simparica. The U.S. Food and Drug Administration (FDA) issued a new warning this past week alerting pet owners and veterinarians of the potential for muscle tremors, ataxia and seizures in dogs and cats when treated with flea and tick drugs that are in the isoxazoline class. These include Bravecto, […]

FDA warning: Pet flea and tick medications could cause seizures

FDA warning: Pet flea and tick medications could cause seizures

The federal Food and Drug Administration has issued a warning about four chewable flea and tick medications, cautioning that the products could lead to neurological issues such as seizures. The FDA is working with manufacturers that use the class of drugs isoxazoline in their products to include a clearer warning on the label, and is […]

Special Report: FDA Opioid safety program fails public

Special Report: FDA Opioid safety program fails public

The Food and Drug Administration knew for years rogue doctors were wrongly prescribing the most potent opioids on the market by subverting the agency’s oversight program. Yet the FDA accepted the word of pharmaceutical companies administering the program that they were policing the doctors. But they weren’t, and patients died. More than 4,000 documents, obtained […]