Previously, this pathway was initially supported by the 2018 FDA Final Guidance for pre-approval communications. Since 2018, biopharma manufacturers are permitted to share unbiased, factual, accurate, ...

or design to our office or to Purdue's authorized agent (for commercial products) for approval. If the product in question is not a University-related product, Trademarks and Licensing will NOT ...

The Iowa Department of Health and Human Services says they've reviewed thousands of products ... were originally approved were now deemed "non-compliant." "We just want information on how to ...

Amneal has received its first product approval in China. Sevelamer carbonate was approved and is expected to launch shortly. In addition, the company expects to launch oseltamivir phosphate in ...

Marotta cited the protein’s categorization as a Class III device, small market size and production costs as current barriers to industry interest in getting FDA approval. When product developers ...

The product ... received approval for,” he said. Anderson noted the approval significantly enhances the company’s Asia Pacific presence for Remplir. With a strong balance sheet of $31.7m ...

--(BUSINESS WIRE)--Alliance Medical Products ("AMP”) announced today, at the AAPS Annual Meeting and Exposition, the U.S. Food and Drug Administration (FDA) has granted approval to manufacture a ...

A startup launched at Osaka University announced Tuesday that it has applied for government approval to commercially sell heart muscle cell sheets developed ... treatment product made from iPS ...

Curasite is the third product approved for marketing in the United ... or revise any forward looking statements to reflect new information or the occurrence of unanticipated events or otherwise ...

Sept. 4 -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has received its first U.S. Food and Drug Administration (FDA) product approval at its ...