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4 Jun 2024, 5:37 pm by Yosi Yahoudai
The FDA is not required to follow the group’s advice and is expected to make its final decision by August, but the negative opinion could strengthen FDA’s rationale for rejecting the treatment. [read post]
4 Jun 2024, 9:57 am by Rebecca Tushnet
Also, even if the FDA cautioned manufacturers not to use “Maximum Strength” claims, “the FDA’s regulations or views are irrelevant or at least not dispositive when it comes to determining whether a reasonable consumer would be deceived or misled under GBL §§ 349-50. [read post]
3 Jun 2024, 2:15 pm by News Desk
Production of the product has been suspended while FDA and the company continue their investigation as to the source of the problem. [read post]
3 Jun 2024, 10:18 am by FRANK VINLUAN - MEDCITY NEWS
Moderna’s mResvia is now the third FDA-approved RSV vaccine and the first one based on mRNA technology. [read post]
3 Jun 2024, 9:09 am by News Desk
According to details published online by the Food and Drug Administration (FDA), the recall was initiated May 17, 2024, and is ongoing. [read post]
3 Jun 2024, 5:19 am by Rebecca Tushnet
The FDA’s own request for comments also demonstrated lots of varied understandings. [read post]
2 Jun 2024, 10:33 am by Kurt R. Karst
In celebration of the OWH anniversary, FDA Commissioner Dr. [read post]
1 Jun 2024, 6:01 pm by Bill Marler
The FDA is conducting whole genome sequencing to determine if this sample is related to an ongoing Salmonella outbreak investigation. [read post]
1 Jun 2024, 4:26 pm by Coral Beach
The FDA has reported that the recall could be related to an ongoing outbreak. [read post]
1 Jun 2024, 4:03 pm by News Desk
Food and Drug Administration (FDA) informed of its recall process to ensure that consumers are properly alerted. [read post]
1 Jun 2024, 10:35 am by Bill Marler
Over the last weeks the FDA has been posting increasing numbers of illnesses linked to an unknown food product. [read post]
1 Jun 2024, 9:00 am by Staff
The manufacturers of weight loss drugs and the doctors who prescribe weight loss drugs need to understand FDA compliance rules, how to prescribe the drugs, and how to monitor the use of the drugs The post Weight Loss Drugs and FDA Compliance appeared first on Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law. [read post]
31 May 2024, 9:05 pm by Gloria Lyu
Food and Drug Administration (FDA) in January 2024 issued guidance on gene therapy products that use such technology. [read post]
31 May 2024, 4:09 pm by News Desk
At this time, the FDA is not aware of any illnesses associated with these products and the FDA does not anticipate any impact on the supply of infant formula based on the recall of these products. [read post]
31 May 2024, 6:04 am by Overhauser Law Offices, LLC
Any product labeled as “tirzepatide” that is not sold by Lilly is not FDA-approved and could be dangerous. [read post]