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Compliance Public Health Life Sciences

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Ropes & Gray LLP

Closeout Requirements During Appeals of Terminations of NIH Research Grants

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On July 7, 2025, the National Institutes of Health (NIH) Office of Policy for Extramural Research issued NOT-OD-25-128, titled “Guidance on Enforcement of Closeout Requirements During the Appeals Process” (the Notice). The...more

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

Holland & Knight LLP

NIH Cuts Research Funding for Indirect Costs

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The National Institutes of Health (NIH) published guidance late on Feb. 7, 2025, setting the indirect cost rate for NIH grants at 15 percent, replacing the negotiated indirect cost rates at many universities, which typically...more

Smart & Biggar

Health Canada proposes to amend the Food and Drug Regulations and Medical Devices Regulations to address shortages

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On December 28, 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages (see our previous article regarding Health Canada’s...more

Akin Gump Strauss Hauer & Feld LLP

In Waning Days of the Current Administration, FDA Announces Red No. 3 Ban

On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022...more

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