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© 2021 MJH Life Sciences and Pharmaceutical Executive. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Executive. All rights reserved.
October 21, 2021
FDA is expanding its Emerging Technology Program (ETP) and providing more support for new drug applications (NDAs) that present advanced manufacturing technologies, but the agency and industry face key challenges in advancing these initiatives.
October 15, 2021
Word is out that the White House will name cardiologist and research pro Robert Califf to the top FDA job, a position he held for almost a year at the end of the Obama administration. But he may face opposition in the Senate.
October 12, 2021
New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.
October 01, 2021
Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional sources of information into research and approval processes.
September 27, 2021
Critics say FDA is either acting too fast and risking public safety—or too slow, mired in rules while ignoring important scientific findings.
The stars finally may be aligned for Americans to gain greater access to alternative biotech therapies in the coming months.
September 21, 2021
If the debate over vaccines for adults and the need for extra booster shots has been heated, FDA will face even more scrutiny over the safety and value of vaccinating children under age 12.
September 20, 2021
FDA’s Vaccines and Related Biological Products Advisory Committee announces its recommendations for the authorization of a third dose of the Pfizer/BioNTech Comirnaty vaccine.
September 14, 2021
But accelerated approval program faces scrutiny.
FDA is launching a program to test the safety and suitability of novel inactive ingredients for use in new drugs and biologics.