European Commission Signs New Supply Deals With Pfizer and Moderna
The EU has struck new supply agreements with Moderna and Pfizer, boosting its total COVID-19 vaccine arsenal to up to 2.6 billion doses, enough to inoculate the bloc’s 446 million…
GSK and Vir Biotechnology Expand Monoclonal Antibody Partnership
GlaxoSmithKline (GSK) and Vir Biotechnology have teamed up to develop monoclonal antibodies for respiratory viruses, building off an existing agreement struck last year to develop COVID-19 therapies. Source: Drug Industry…
Woodcock Rebuffs Proposed ‘Firewall’ Between FDA Staff Following Aducanumab Dispute
Acting FDA Commissioner Janet Woodcock rejected a proposal to put up a “firewall” between FDA staff involved in pre-submission interactions and staff working on post-submission drug and biologic reviews and…
UK to Start World’s First COVID-19 Human Challenge Trial
A specially convened UK clinical trial ethics committee has given the go-ahead for a COVID-19 human challenge study that is slated to start within weeks to help inform further vaccine…
New York Contract Manufacturer Hit for Repeat Observations
Failure to control product that did not conform to specifications, and failure to validate software landed contract manufacturer Viant AS&O Holdings in hot water with the FDA following an Oct.…
FDA Issues Final Guidance on New Review Path for Safer Technologies
The FDA is introducing a new review program for medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or condition…
TGA Investigates COVID-19 Tests and Emerging Variants
Australia’s Therapeutic Goods Administration is conducting a postmarket review of all COVID-19 point-of-care and laboratory tests listed in the Australian Register of Therapeutic Goods to ensure that they can detect…
Medtronic Hit for Failing to Properly Investigate Reports of Device Failure
Complaints involving the possible failure of a device to meet any of its specifications weren’t evaluated and investigated by Medtronic’s Heart Valves Division, according to a Form 483 the firm…
Repeat Observations Dog Arizona Mask Maker
Numerous repeat observations including failure to establish corrective and protective action (CAPA) and design control procedures were observed during an Oct. 5-7, 2020 FDA inspection of CPAPNEA Medical Supply’s Phoenix,…
MHRA Issues Guidance on Stand-Alone Software
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued updated guidance that clarifies the deadlines for stand-alone software that must carry the UK conformity assessment mark (UKCA) for applications…
- Go to the previous page
- 1
- 2
- 3
- 4
- 5
- 6
- 7
- 8
- …
- 610
- Go to the next page