pharmaphorum12d
Gottlieb sets out vision for more transparent FDA, better rare disease guidance
But Gottlieb’s remarks on establishing greater transparency in FDA decision-making on new drug approvals, and creating new ‘pathways’ for rare disease were probably the most eyecatching for ...
Hosted on MSN2mon
FDA must disclose more COVID-19 vaccine records, US judge rules
The lawsuit, filed in late 2021, attracted attention after the FDA said it could take decades to process and disclose records to Public Health and Medical Professionals for Transparency ...
pharmaphorum2d
The end of drug shortages begins with data transparency
Functional and cross-functional teams expect greater data transparency to make compliance easier, which would mitigate the risk of drug supply gaps. Every day that a drug isn't available costs a ...
The New England Journal of Medicine9mon
Interview with Dr. Jerry Avorn on the FDA Amendments Act of 2007 and the effort to make data on drug safety more transparent and available.
Jerry Avorn is a professor of medicine at Harvard Medical School and a member of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Stephen Morrissey ...