BioWorld - Saturday, February 14, 2026

Articles Tagged with ''FDLI''

U.S. Capitol building
FDLI Advertising and Promotion Conference

US data privacy environment a tangled web for med-tech companies

Nov. 3, 2023
By Mark McCarty
Privacy considerations have been front and center for U.S. federal government agencies for more than two decades, but several states have jumped into the privacy arena with their own legislative imperatives. While companies in the medical device industry would like to see a less imposing thicket of related enforcement requirements, Nancy Perkins of Arnold & Porter LLP said there is little prospect that Congress will relieve the predicament with anything resembles preemptive legislation.
Read More
U.S. at night from space with circuit board overlay
FDLI Digital Health Conference

US FTC preparing to ‘think outside the box’ regarding the definition of health information

Dec. 1, 2022
By Mark McCarty
The U.S. Federal Trade Commission (FTC) has moved decisively in the area of mergers and acquisitions recently, but the agency also has a footprint in the enforcement space for health data disclosure. The FTC’s Ronnie Solomon said in a Dec. 1 public meeting that the agency will begin “thinking outside the box about what health information is in the 21st Century,” adding that the FTC is eyeing a more stringent enforcement regime regarding personal health data disclosures in the coming new year.
Read More
Gavel and First Amendment
FDLI Advertising and Promotional Conference

Supreme Court may provide new vectors for commercial speech enforcement

Oct. 14, 2022
By Mark McCarty
The U.S. FDA’s regulation of commercial speech under the First Amendment has been controversial and has handed the agency several losses in court, but Arun Rao of the U.S. Department of Justice let it be known that DOJ is still keen on commercial speech enforcement. Rao said the case of Gonzalez v. Google, which will be heard by the Supreme Court, is an example of potentially precedent-setting litigation, and that manufacturers of drugs and devices may experience an uptick in enforcement depending on where the Supreme Court lands in Gonzalez.
Read More
FDLI Advertising and Promotional Conference

Supreme Court may provide new vectors for commercial speech enforcement

Oct. 13, 2022
By Mark McCarty
The U.S. FDA’s regulation of commercial speech under the First Amendment has been controversial and has handed the agency several losses in court, but Arun Rao of the U.S. Department of Justice (DOJ) let it be known that DOJ is still keen on commercial speech enforcement. Rao said the case of Gonzalez v. Google, which will be heard by the Supreme Court, is an example of potentially precedent-setting litigation, and that manufacturers of drugs and devices may experience an uptick in enforcement depending on where the Supreme Court lands in Gonzalez.
Read More
10-22-machine-learning-hero
2022 FDLI Annual Conference

AI developers should build robust change control protocols despite absence of FDA guidance

June 20, 2022
By Mark McCarty
The U.S. FDA may be the most advanced regulatory agency when it comes to artificial intelligence (AI) and machine learning (ML), but developers of these products still have little in the way of FDA guidance to work with in many instances. Cassie Scherer of Dublin-based Medtronic plc, told attendees at this year’s Food and Drug Law Institute annual conference that they should have a product change control protocol ready to go despite the absence of FDA guidance on the subject, an effort that will increase time to market but pay eventually big dividends.
Read More
2022 FDLI Annual Meeting

Shuren says FDA out of medical device single review program for now

June 15, 2022
By Mark McCarty
Regulatory harmonization for medical technology often seems more the stuff of gauzy dreams than bare-knuckle reality, but the Medical Device Single Review Program (MDSRP) is at the top of the list for a lot of device makers. Jeff Shuren, director of the U.S. FDA’s Center for Devices and Radiological Health (CDRH) device center, told an audience at this year’s annual meeting of the Food and Drug Law Institute (FDLI) that while the agency is very keen on the MDSRP concept, the agency would need help from Congress with the statute in order to take part, and thus the FDA will not be taking part in the MDSRP effort for now.
Read More
2022 FDLI Annual Meeting

Califf says his return to FDA will bring changes to supply chain issues

June 14, 2022
By Mark McCarty
U.S. FDA Commissioner Robert Califf offered the keynote address at this year’s annual meeting of the Food and Drug Law Institute (FDLI), revisiting recent events that have roiled the agency’s staff and reputation. Califf made a point of emphasizing the need for new statutory authorities in connection with the supply chains for FDA-regulated products, and remarked that his return to the agency will not be a reversion to the norm in this context.
Read More