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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
News
19 April 2024
The U.S. Food and Drug Administration (FDA) has announced the establishment of the “Center for Drug Evaluation (CDER) Center for Clinical Trial Innovation” (C3TI). C3TI is...
News
19 April 2024
On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative ...
News
18 April 2024
While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent ...
News
12 April 2024
On 10 April 2024 the European Parliament adopted its position on the draft text on the revision of the European Union’s (EU) general pharmaceutical legislation, also referred to as...
News
04 April 2024
On 28 March, the U.S. Commerce Department, Bureau of Industry and Security (BIS) published a list of entities that have been identified as having made a boycott-related request in order to...
News
02 April 2024
The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and...
News
01 April 2024
On February 16, 2024, the U.S. District Court for the District of Oregon issued a ruling in Pharmaceutical Research and Manufacturers of America (PhRMA) v. Stolfi, granting in part...
Insights and Analysis
29 March 2024
Advancements in medical technology make healthcare and radiopharmaceutical companies attractive investment prospects. And we are seeing this interest in real time. However, acquiring...
News
21 March 2024
Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological...
