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14 May 2016, 9:08 am by Eric Needs
The FDA said it is adding a warning to drug labels for all olanzapine-containing products, describing a “rare but serious”The post Antipsychotic Drug Can Cause Severe Skin Rash, FDA Warns appeared first on Legal Reader. [read post]
15 Dec 2020, 7:12 pm by Staff
FDA granted an Emergency Use Authorization to a COVID-19 vaccine developed by Pfizer, Inc. [read post]
18 Oct 2023, 9:00 am by Michael H Cohen
The post When Will FDA Likely Regulate Your Product as an OTC Drug and Not a Cosmetic? [read post]
8 Jun 2016, 8:59 am by Eric Needs
The FDA isThe post FDA Says Pfizer Opioid Meant to Deter Abuse Has Tampering Risk appeared first on Legal Reader. [read post]
12 Sep 2023, 7:02 am by FRANK VINLUAN - MEDCITY NEWS
Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review. [read post]
23 Nov 2021, 5:33 am by Michael H Cohen
The post FDA & FTC Legal Update: Dietary Supplements and Cosmetics (Part 1) appeared first on Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law. [read post]
30 Oct 2023, 12:09 pm by Carabin Shaw
FDA Warns Parents of High Lead Levels in WanaBana Fruit Pouches According to a KSAT News report, the FDA has issued a warning to parents over high lead in popular food pouches for children. [read post]
6 Jun 2016, 3:01 pm by Jay W. Belle Isle
On Wednesday, June 8, Representative Mike Fitzpatrick announcing medical device and FDA reform bills. [read post]
12 Oct 2023, 8:04 am by Bergeson & Campbell, P.C.
Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). [read post]
29 Sep 2023, 8:26 pm by James A. Boiani, Megan Robertson
Unlike past proposals from FDA and Capitol Hill, FDA has taken a simple approach: laboratories that make LDTs for clinical use are manufacturing in vitro diagnostic medical devices (“IVDs”) for commercial distribution, and as such must eventually comply with FDA’s already-established IVD requirements. [read post]
12 Oct 2023, 8:04 am by Bergeson & Campbell, P.C.
Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). [read post]
26 May 2021, 11:40 am by Tom Lamb
From the May 2021 Ocaliva FDA Drug Safety Communication we get this statement about what the FDA is doing: We added a new Contraindication, FDA’s strongest warning, to the Ocaliva prescribing information and patient Medication Guide stating that Ocaliva should not be used in PBC patients with advanced cirrhosis. [read post]
14 Jul 2020, 6:51 am by Robert Kraft
” In a statement, FDA Commissioner Hahn said, “With the authorization of these tests, the FDA is helping address concerns in anticipation of this upcoming flu season during the COVID-19 pandemic, which might be especially worrying for some Americans. [read post]
13 Jul 2023, 12:44 pm by Stephen Honig
The FDA has a Task Force with focus on companies subject to FDA regulation/clearances. [read post]