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© 2021 MJH Life Sciences and Applied Clinical Trials Online. All rights reserved.
© 2021 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
February 05, 2020
FDA’s new commissioner, Stephen Hahn, announced his priorities at an FDA “all hands” staff meeting last week. Jill Wechsler reports.
January 03, 2020
While not setting any records for the rapid approval of new drugs in 2019, FDA did speed a number of important new therapies to patients, writes Jill Wechsler.
December 05, 2019
FDA’s Office of New Drugs restricting aims to improve scientific exchange and information sharing among review professionals.
December 01, 2019
Examining the unique aspects involved in preparing and submitting marketing applications for proposed treatments for rare disease.
October 29, 2019
CDER's Rare Disease Cures Accelerator initiative looks to foster a coordinated research approach and methods that can expedite development of drugs to treat some of the 7,000 rare diseases.
July 09, 2019
Concerns for patient safety are raised with the recent surge in new drugs receiving fast-track FDA approval. Jill Wechsler reports.
June 14, 2019
FDA draft guidance for modernizing the approach to clinical trial design for oncology drugs and biologics look to make clinical trials more efficient while maintaining patient safety.
April 11, 2019
A new CDER “knowledge management” approach will see companies submit applications that can be transmitted to experts from multiple disciplines able to assess applications for new drugs and biologics in a timely and efficient manner.
December 01, 2018
Supporting real change in clinical trials is more than just lip service-it’s putting the information out
there transparently for all stakeholders to measure and make decisions.
September 01, 2018
Jill Wechsler details new FDA policies to streamline drug development, including the design of “seamless” trials.