Recent media reports push to the forefront the threat posed by dry labs that falsely claim to test products for manufacturers. Manufacturers should qualify and regularly audit labs to reduce this risk, which places them on the hook for potential GMP violations, industry leaders say.
Dietary supplement manufacturers are testing their products more often and more thoroughly in response to increasing enforcement of good manufacturing practices, but they need to ensure third-party labs actually test products and are not “dry,” industry leaders warn.
A dry lab that reports false results based on insufficient or nonexistent tests places public health and manufacturers’ reputations at risk, Frank Jaksch, founder and CEO of ChromaDex Inc., said...
The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
For the Trump Administration, the blockbuster GLP-1 drugs for obesity have become a poster child for the disparity between US and foreign prices.
Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.
