News

JD Supra2d
Are FDA Review Timelines Slipping? What Companies Need to Know
As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and ...
JD Supra2d
Staying Prepared Amid FDA Changes
Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers ...
The Regulatory Review11d
Restoring FDA’s Premarket Review Powers
In response, the U.S. Congress passed the Federal Food, Drug and Cosmetic Act of 1938, granting FDA with “premarket review” ...
Healthcare Packaging11d
Avoid FDA warning letters with expert compliance strategies
Discover industry-tested approaches to strengthen quality systems and navigate regulatory scrutiny in this comprehensive ...
FDA Updates COVID-19 Vaccine Regulations—Here’s What to Know
Only people aged 65 and up, along with certain groups, will be eligible to receive booster shots. FDA officials are asking for more data around the vaccine’s effectiveness for people who are otherwise ...
Star Tribune1mon
As FDA slashes workforce, number of new medical devices reaching the public has fallen
U.S. Food and Drug Administration approvals ... Pending applications for these devices without direct predecessors in regulatory files, though, also declined to a five-year low, according to ...
Upheaval at FDA pushes some biotech firms to move early trials out of US
Reuters, the news and media division of Thomson Reuters, is the world’s largest multimedia news provider, reaching billions of people worldwide every day. Reuters provides business, financial, ...
Orthopedics This Week12d
Sawbones® and Numalogics Achieve First-Ever FDA Qualification of an Orthopedic Device Mechanical Test Under MDDT Program
In a groundbreaking advancement for the orthopedic device industry, Sawbones and Numalogics, Inc. are proud to announce that ...