A coalition of over 20 leading health organizations is calling on the U.S. Food & Drug Administration (FDA) to enforce ...

Makary, a prominent voice on U.S. health care practices throughout his career, spent 22 years at Hopkins Medicine ...

US Health Secretary Robert F. Kennedy Jr.’s initiative to increase oversight of infant formula safety will test the FDA’s ...

While recent draft guidance from the Food and Drug Administration pertaining to artificial intelligence-enable medical ...

Regular inspections are being conducted at the Class A and Class B medical devices manufacturing units. Based on the revised GMP, a revised checklist was also prepared and made effective in the ...

Autolus has a dedicated commercial manufacturing site in play at Stevenage in the UK, which has already passed an FDA inspection and has the capacity to supply Aucatzyl globally, and has ...

The inspection, conducted from 20-24 January, follows the site’s opening in February 2023. This is the first inspection of a routine process by ANSM to ensure compliance with Good Manufacturing ...

J&J acquired the IVL device maker Shockwave Medical last year for $13.1 billion, and Boston Scientific agreed to buy Bolt Medical in January for up to $664 million.