US regulators laid out new guidelines for approving custom-made treatments for individual patients, a move that could bring the promise of gene editing to more people with devastating diseases.Food and Drug Administration Commissioner Marty Makary and Vinay Prasad,

Vinay Prasad and Tracy Beth Høeg mix skepticism with new ways to define risk in pursuing sweeping changes to vaccine policy at the FDA.

With new draft guidance, FDA continues prior efforts to reduce the need for comparative clinical studies in biosimilar development and speed

By emphasizing analytical studies instead of routine clinical trials, the FDA signals its intent to reduce the cost (often estimated at $100 million to $300 million) and time (typically 6–9 years) required to bring biosimilars to market. 3

Qualifying for *** COVID-19 vaccine really depends on your age, health, and insurance coverage. And now most people don't meet the guidelines. On Wednesday, the Food and Drug Administration approved updated vaccines but limited their use for many Americans.

Biosimilar developers should expect case-by-case evaluations, as the draft offers no hard rules on when CES will be waived. Developers are encouraged to consult the FDA early to understand evidentiary expectations and to monitor potential legal challenges from both originators and competitors.

Tweets would have to include all risks and benefits. — -- Tweeting about the most commonly prescribed drugs will be nearly impossible if new FDA guidelines on the use of social media by drug and medical device companies are adopted, experts said.