FDA Act Bolsters AP Inspections
This article was originally published in The Silver Sheet
PARTICIPATION IN FDA'S ACCREDITED PERSONS INSPECTION PROGRAM could rise thanks to the FDA Amendments Act, which reauthorizes MDUFMA and strengthens the AP inspection program by removing administrative barriers. The law, enacted Sept. 27, also requires unique device identifiers and gives CDRH $39 million to shore up postmarket surveillance activities.
You may also be interested in...
Pharma manufacturing is operating well below normal levels in India, disrupted by labor absenteeism and supply chain issues amid the ongoing lock-down in the country, though the government is actively engaged in addressing bottlenecks. A speedy recovery is vital not just for domestic supplies.
Moderna is pursuing a single-antigen strategy even though some of its mRNA vaccines have included multiple antigens; the SARS-CoV-2 spike protein likely provides the best antigen for developing immunity against the virus.
Latest warnings also include second and third businesses in US cannabidiol and hemp sector found making unlawful claims for treating and preventing COVID-19. Four of five firms warned apparently responded by removing violative claims from websites and social media posts.