FDA

“There's a lot of third-party audit information out there. Could we take that and apply it into our inspectional planning process?” says Office of Dietary Supplement Programs Director Cara Welch.

After years of regulatory setbacks, Amphastar has secured FDA approval for its first pen device combination product, targeting a $585m Forteo market.

“We have rarely, if ever, enforced this requirement” FDA says announcing enforcement discretion regarding requirement for disclaimer about supplement structure/function and other label claims to be printed on every panel of a product’s package.

After multiple warning letter campaigns, the US FTC has claimed a win as Teva’s request to remove hundreds of Orange Book patent listings will pave a generic competition path for more than 30 products.

The US FDA’s approval of the first generic rival to Mayne Pharma’s Imvexxy (estradiol) comes days after the agency released product-specific guidance, which was demanded by the originator through citizen petitions.

CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.

Sunscreen products industry and public health advocacy groups have been critical that FDA has not approved a new filter since 1999 even as countries in Europe and other regions allow using numerous additional ingredients in sunscreens.

FDA’s proposed order follows its review of OMOR DSM-Firmenich submitted showing bemotrizinol, at concentrations up to 6%, is generally recognized as safe and effective and can be added as an active ingredient to sunscreen monograph.

FDA looks to Congress for authority to require registration for all supplements available for sale in US for public-facing product listing but no authority can produce list of dietary ingredients available pre-DSHEA.

The US FDA has delivered its December batch of product-specific guidances for generic development, marking only the second timely release of the year.

With Richard Pazdur’s abrupt exit marking the fifth CDER leadership change in a year, the AAM is urging continuity and stability amid the ongoing turbulence.

CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.