News & Analysis as of

Center for Drug Evaluation and Research (CDER) Compliance

Gardner Law

FDA Layoffs, RFK Jr. at HHS, and What This Means for FDA-Regulated Companies

Gardner Law on

In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more

Lowenstein Sandler LLP

A Look Ahead: US FDA And Medical Device Regulations In 2021

Lowenstein Sandler LLP on

The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

Health Care Compliance Association (HCCA)

Draft Guidance to Increase Seniors in Cancer Trials a 'Good First Step'

Report on Research Compliance 17, no. 5 (May 2020) - Study sponsors should be making additional efforts to enroll older individuals in cancer trials, incorporating such strategies in study design and recruitment methods,...more

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