Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, AN2, Astrazeneca, Beigene, BMS, Cstone, Epygenix, Immune-Onc, Kato, Lupin, Moderna, Poxel, Sanofi, Valbiotis, Zai Lab.
The FDA’s device center has been eyeing an overhaul of its Quality System Regulation (QSR) for several years, and the latest development is the scheduling of a March 2 advisory committee hearing to review the proposal. The default assumption is that the agency will post the draft rule prior to the hearing, although the routine two-day window for reviewing FDA meeting materials prior to an advisory hearing might leave stakeholders with insufficient time to examine the agency’s proposal.
India’s health care industry stakeholders have been left scratching their head as authorities, who have championed self-reliance and increased supplies, provided mixed signals in recent notices.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bonalive, Evoendo, Novacyt, Oncimmune.
Drug companies won another round in their battle with the U.S. Department of Health and Human Services (HHS) over how many contract pharmacies must be given the steep discounts dictated under the 340B drug pricing program aimed at helping public clinics and hospitals provide charity care.
As the Biden administration continues to play musical chairs with key U.S. federal health leadership positions, its latest move is naming Francis Collins to serve as science adviser to the president and co-chair of the President’s Council of Advisers on Science and Technology.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Avenue, Biontech, Celcuity, GBT, Hemogenyx, Hillstream, Jixing, Lexeo, Mirati, Moderna, Pfizer, Revive, Sirnaomics, Swanbio.
The selection of Robert Califf to run the U.S. FDA might seem like a safe move on the part of the White House, but some believe his prior experience at the FDA does not necessarily suggest an acceptance of the regulatory status quo. Peter Pitts, president of the Center for Medicine in the Public Interest, told BioWorld that while Califf is “not a flashy pick,” Califf possesses a very keen understanding of the need to modernize the FDA’s practice of regulatory science, which should be a welcome bit of news for makers of drugs and devices.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Guard Medical, Rapid Medical, Tandem Diabetes Care.
Over the past few years, China has been quick to make promises to improve its regulatory and patent schemes for biopharmaceuticals and medical devices in keeping with its World Trade Organization (WTO) commitments, but it’s been slow to fulfill those promises – at least in the eyes of the Office of the U.S. Trade Representative (USTR).
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