SUBSCRIBE
SUBSCRIBE
News   Policy

Drug Firms Must Speed Major Trial Risk Reports - FDA; Rule Requires More Notification of Safety Problems

September 29, 2010 | 
1 min read

WASHINGTON, Sept 28 (Reuters) - Drugmakers studying experimental drugs in anticipation of U.S. sales must now tell regulators about serious health problems that arise during clinical trials within about two weeks.

Regulatory
Food and Drug Administration (FDA)
MORE ON THIS TOPIC
Government
Trump’s CDC Pick Says Vaccines Are Safe, Promises To Keep Them Available
June 26, 2025
 · 
2 min read
 · 
Tristan Manalac
Successful businessman standing in front of multiple pathways, making a decision for the right move. A symbol of great investment and positive progress in the development of business. stock illustration
Mergers & acquisitions
Lilly-Verve Proxy Filing Reveals Tumult After Departure of FDA’s Marks
June 26, 2025
 · 
4 min read
 · 
Annalee Armstrong
Health and Human Services Secretary Robert F. Kennedy Jr. makes remarks at an event announcing the MAHA (Make America Healthy Again) Commission, Thursday, May 22, 2025, in the East Room of the White House. (Official White House Photo by Joyce N. Boghosian)
Vaccines
RFK Cuts U.S. Funding From Vaccine Alliance Gavi, Claims Group ‘Ignored the Science’
June 26, 2025
 · 
2 min read
 · 
Tristan Manalac
2006 James Gathany Captured by James Gathany, Centers for Disease Control's biomedical photographer, this 2006 image depicted the exterior of the new "Tom Harkin Global Communications Center", otherwise known as Building 19, located on the organization's Roybal Campus in Atlanta, Georgia. The facility houses the CDC's Information Center/Library, auditoria and meeting halls, which are used to accommodate in-house staff meetings, and national/international conferences hosted by the CDC, and the National Center for Health Marketing's, Division of Creative Services, which includes a full service television broadcast facility. The exhibit area currently features the "Global Symphony", the first of several permanently installed exhibitions, and changing exhibitions that focus on a variety of public health topics. The exhibits in the Center are self-guided, and require no advance reservations. Additional curriculum-based exhibits and programming will be added in the future. Tom Harkin Global Communications Center Exhibit Area Centers for Disease Control and Prevention - 1600 Clifton Road, N.E., Atlanta, Georgia 30333 - Hours: Monday – Friday, 9 am – 5 pm, except for federal holidays Admission is free - Government-issue photo ID is required for entry. Please note that CDC is a working federal facility and as such does not provide public tours of its campus and laboratories. - For more information please call 404-639-0830.
Vaccines
What To Watch for as ACIP’s New Era Begins
June 25, 2025
 · 
3 min read
 · 
Dan Samorodnitsky