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4 Jun 2024, 5:37 pm
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, 10:00 am
FDA updates that data once a year at the close of its fiscal year. [read post]
4 Jun 2024, 9:57 am
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, 9:06 pm
Why the FDA? [read post]
3 Jun 2024, 2:15 pm
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, 11:47 am
The post The FDA Wants To Reschedule Cannabis. [read post]
3 Jun 2024, 10:18 am
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
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
The FDA’s own request for comments also demonstrated lots of varied understandings. [read post]
2 Jun 2024, 12:07 pm
The FDA will make the final decision, likely in August. [read post]
2 Jun 2024, 10:33 am
In celebration of the OWH anniversary, FDA Commissioner Dr. [read post]
1 Jun 2024, 6:01 pm
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
The FDA has reported that the recall could be related to an ongoing outbreak. [read post]
1 Jun 2024, 4:03 pm
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
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
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
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
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, 8:11 am
The FDA warned consumers not to use baby formula produced at a certain Abbott […] [read post]
31 May 2024, 6:04 am
Any product labeled as “tirzepatide” that is not sold by Lilly is not FDA-approved and could be dangerous. [read post]