Rogue FDA Tweeters Archive Inspection Data, Fearing Deletion By Trump
Followers of rogue FDA twitter site AltFDA answered a call to back up inspection citations data the Obama administration made public in case the Trump administration erases it from the FDA website.
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FDA's “Wayback” archive; EMA's whistleblower policy; IPRF's drug ID plan; reprieve for DMF holders; investigational compounding; PK/PD for kids; ISPE on quality culture; PDA on quality risks.
US FDA considering approach that is similar to, but more stringent than, influenza strain changes, CBER Director Marks says. Meanwhile, vaccine developers face challenge of when to change antigens to get the best results, NIH’s Graham notes. As FDA and sponsors gain more experience with tweaking the vaccines to account for new coronavirus variants and strains, the process may be expedited further.
Agency’s struggle to meet user fee commitments despite travel restrictions expected to worsen as pandemic continues into 2021.