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Pfizer seeks to help FDA release of vaccine data
... U.S. Food and Drug Administration used in licensing the company's COVID 19 vaccine, a lawsuit that plaintiffs are suing for the data say is premature. Pfizer 's lawyers told U.S. District Judge Mark Pittman on January 21 that he wanted to help the FDA avoid disclosure of trade secret and confidential commercial information. On Tuesday night, a group of doctors and scientists who sued last year over public access to the FDA's Pfizer licensing records said in a court filing that the company's bid ...
Updated: 01/26/2022
Biden has yet to pick a permanent head of the FDA
... nominate someone. The White House would love to have a permanent pick in place and wants to nominate the right person, but I don't know an update on the timeline for that, according to the Hill. Suggesting turmoil at the leaderless agency, two senior FDA officials plan to leave in the coming months over disagreements over issuance of booster shots. Dr. Joe Manchin , acting commissioner of the FDA, was reportedly ruled out as nominee earlier this month in spite her decades of experience at the agency ...
Updated: 09/01/2021
FDA temporarily suspends ban on Juul e-cigarettes
... e-cigarettes. The marketing denial order is temporarily suspended, but it doesn't rescind, according to the tobacco division of the agency. All electronic nicotine delivery systems or ENDS products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed, according to FDA Tobacco . The stay and the agency's review do not constitute authorization to market, sell or ship JUUL products. The FDA had issued an order on June 23 banning the sale of Juul e-cigarettes....
Updated: 07/06/2022
FDA approves e-cigarettes approved for sale in U.S.
... a sweeping review of whether millions of cigarette alternatives benefit public health, British American Tobacco Plc s e-cigarette Vuse and its tobacco-scented pods cleared to combat smoking. Vuse is the first vapes from a major manufacturer to win FDA backing to continue U.S. sales, with the agency saying it can help users reduce exposure to harmful chemicals The FDA is developing millions of applications - including some from BAT competitors such as Juul Labs Inc. While the products under review ...
Updated: 10/13/2021
FDA moves to diversify baby formula supply chain
... administration is making strides to help foreign makers stay on the shelves. In an effort to diversify the baby formula U.S. market, the Biden administration is making strides to help foreign makers stay on the shelves. The Food and Drug Administration FDA said that the need to diversify and strengthen the supply chain is more important than ever. The shutdown of a major infant formula plant, compounded by unforeseen natural weather events, shows how vulnerable the supply chain has become, the agency ...
Updated: 07/06/2022
FDA issues warning to Philips after patients, medical suppliers claimed they were unaware of recall
The Food and Drug Administration FDA sent a warning to Philips Respironics after patients and medical suppliers claimed they were unaware that certain breathing assistance machines had been recalled. The Food and Drug Administration FDA sent a warning to Philips Respironics after ...
Updated: 03/13/2022
FDA panel backs Moderna's COVID-19 vaccine for kids under 5
... endorsed a second brand of COVID- 19 vaccine for school-age children and teens. The Food and Drug Administration s outside experts voted unanimously that Moderna 's MRNA vaccine is safe and effective enough to give kids ages 6 to 17 years old. If the FDA agrees, it would become the second option for those children to join Pfizer 's vaccine. The FDA panel will meet Wednesday to discuss tot-sized shots from Moderna and Pfizer for the littlest kids, those under 5. Moderna 's COVID 19 vaccine is available ...
Updated: 06/14/2022
FDA appoints Norman Birenbaum as senior public health advisor on cannabis research
The FDA has appointed Norman Birenbaum to be its senior public health advisor on cannabis research and regulatory actions, according to Inside Health Policy. The FDA has appointed Norman Birenbaum to be its senior public health advisor on cannabis research ...
Updated: 09/28/2022
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