Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more
Rare Disease Day took place on February 29, 2024. Created in 2008, Rare Disease Day is observed on the “rarest day of the year”—February 29 in leap years (February 28 in non-leap years)—as a way to galvanize the global rare...more
At some point in the future, NIH may halt funding for clinical trials deemed too underpowered to produce meaningful findings or that fail to meet enrollment goals. To do this, the agency would have to adopt so-called...more
California’s lab and biotech industries provide 435,693 jobs that generate $376 billion in total economic output, according to a new report from Biocom California, an association representing life sciences companies and...more
The Council on Governmental Relations (COGR) is sounding an alarm regarding costs institutions have expended to comply with “new and clarified provisions calling for researchers to disclose all sources of research support and...more
Earlier this month, Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) sent a letter to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) urging both agencies to advance research on the...more
Moderna has been engaged in a patent dispute with the National Institutes of Health (NIH) over whether three NIH scientists should be named as inventors for discovering the genetic sequence that’s central to the vaccine. ...more
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more
Every year, the National Institutes of Health (NIH) spends billions of federal dollars on research and development of new drugs and therapies for treating and preventing serious illnesses....more
The 21st Century Cures Act, signed into law by President Obama on December 13, encourages biomedical research investment and facilitates innovation review and approval processes. Through National Institutes of Health (NIH)...more
The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more