JD SUPRA (PRESS RELEASE)

Manufacturing sites should prepare now for inspections before the U.S. Food and Drug Administration (FDA) resumes routine on-site...

In January 2022, the U.S. Food and Drug Administration (FDA) released finalized guidance on premarket pathways for combination products. While...

[author: Anna Wiktorow] On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices,...

[author: Anna Wiktorow] On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices,...

Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. On February 10, 2022, the...

Cell and gene therapy transactions have increased dramatically over the last few years, in both number and complexity, and have given rise to a...

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and...

On April 14, the U.S. Food and Drug Administration (FDA) released a new draft guidance to industry for increasing racial and ethnic diversity in...

The Food and Drug Administration’s (FDA) user fee programs, which pay the salaries of agency staff who review drug and medical device...