Royal Philips NV may feel it has had enough recent interaction with the U.S. FDA, but the company is now in receipt of a warning letter from the agency over a facility located in Suzhou, China. The FDA was none too fond of the facility’s handling of a contract manufactured data cable used in CT systems because of malfunctions that may have delayed diagnostic imaging procedures, representing yet another regulatory distraction for a company that recently cleared a long-running conflict with the FDA over CPAP machines.
Reliance may be the regulatory buzzword of the moment, but mutual recognition agreements between regulators are much more near and dear to the hearts of device makers. Richard Phillips, director of strategy for Association of British Health Tech Industries Ltd., told an audience of device makers that the U.K. is considering recognition of devices approved and cleared by the FDA, although Phillips said such recognition for 510(k) devices might be less than a simple exercise.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, is the latest to announce a win in the biosimilar space, gaining MFDS approval of Epyztek (SB-17) as the country’s first biosimilar to Stelara (ustekinumab, Janssen Pharmaceutical Inc.) on April 11.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, is the latest to announce a win in the biosimilar space, gaining MFDS approval of Epyztek (SB-17) as the country’s first biosimilar to Stelara (ustekinumab, Janssen Pharmaceutical Inc.) on April 11.
The U.S. FDA’s device center has at times struggled to make the volume of hires under the reigning Medical Device User Fee Agreement (MDUFA), but that wasn’t a problem in fiscal year 2023.
The U.S. FDA’s latest draft guidance on discussions of off-label uses with doctors revisits a controversial subject that has previously migrated into the courts, and by some accounts, may do so yet again. In comments to the docket, the Washington Legal Foundation (WLF) argued that this latest attempt to regulate commercial speech is another example of the agency’s “flagrant disregard for drug and device manufacturers’ free speech rights,” which WLF seemed to suggest is an actionable violation of the First Amendment.
The U.S. FDA has commenced with a pilot program for companion diagnostics (CDx) for oncology therapies, which fulfills in part a 2014 agency guidance on the use of CDx. The FDA expects to enroll only nine reference drugs and the associated companion test, but the pilot program is part of the FDA’s controversial attempt to deal with lab-developed tests (LDTs), specifically those tests that are used to determine whether a patient is likely to respond to a particular oncology treatment.
Artificial intelligence has morphed from a buzzword referencing a popular curiosity to a series of national security and competitiveness considerations, which was reflected in the tone of a recent hearing in the U.S. House of Representatives.
Artificial intelligence has morphed from a buzzword referencing a popular curiosity to a series of national security and competitiveness considerations, which was reflected in the tone of a recent hearing in the U.S. House of Representatives.
The U.S. Federal Trade Commission announced Nov. 21 that it has obtained a civil monetary penalty in the amount of $700,000 from CRI Genetics LLC, an enforcement action taken under the agency’s policy for biometrics information.
