Packaging trade dress would instead focus on the manner in which the manufacturer wraps, labels, boxes or bottles a drug or biologic ... images of tablets and / or capsules on the packaging ...

1 They highlight that although trials have excluded patients with specific chronic medical and psychiatric conditions, the FDA labeling does not restrict treatment to only those in whom they are ...

(WJW) — A popular anxiety drug is being recalled over a ‘life-threatening’ label mistake. In a recall alert for some lots of Clonazepam Orally Disintegrating Tablets the FDA states the ...

As per its latest Enforcement Report, US Food and Drug Administration (USFDA), stated that Dr Reddy's Laboratoties is also recalling a product in the US due to a manufacturing issue. Baltimore-based ...

Two dozen Members of Congress, led by Rep. Rosa DeLauro, are demanding the Food and Drug Administration ban the carcinogenic food dye FD&C Red No. 3, known as Red 3, in food. California banned Red ...

Drug firm Lupin is recalling over six lakh ... is recalling 6,16,506 bottles of Ramipril capsules in strengths of 2.5 mg, 5 mg and 10 mg, the U.S. health regulator said. The affected lot is ...

The US FDA has recently proposed a new draft framework that enables pharma manufacturers to add software to a drug label if they can demonstrate that the software adds clinical benefit to the drug.

Make smarter investments with weekly expert stock picks from the Smart Investor Newsletter Valneva has submitted an application to the U.S. FDA to extend the use of its chikungunya vaccine ...

Alnylam (ALNY) Pharmaceuticals announced that the U.S. Food and Drug Administration or FDA, has accepted for review the Company’s supplemental New Drug Application sNDA for vutrisiran ...