The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

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Labelling FDA Vaccines Communication 40

The Checkup by Singlecare

JULY 11, 2024

The drug’s label recommends doses of 5–60 mg per day. So, anyone taking it should avoid people who have highly infectious diseases like the flu or who recently received a live vaccine. According to studies from 2008 and 2018 , prednisone and non-steroidal anti-inflammatory drugs are equally effective treatment options for gout.

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Dosage Packaging Immunization FDA 94

PharmaShots

APRIL 13, 2023

In 2008, Johnson acquired tissue sealing system developer, SurgRx Pfizer's pharmaceutical segment revenue increased after the acquisitions of Serenex, Encysive Pharmaceuticals, CovX, and Coley Pharmaceuticals Novartis reported a total revenue of $41.4B, under which, its pharmaceutical division faced a revenue loss of $2.6B

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Labelling 40

PharmaShots

MARCH 9, 2023

In addition to serving as Associate Editor-in-Chief of the IEEE Open Access Journal of Circuits and Systems, she has been an Associate Editor of IEEE Transactions on Biomedical Circuits and Systems since 2008. Designation: Global Head Previous company: Merck Global Vaccines (2 yrs. LinkedIn Total experience: 26 yrs.

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FDA Pharmaceutical Companies Pharmaceutical Companies Immunization 40

ISPE

AUGUST 30, 2022

During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. Published 2008. Published May 2012. Guidance for Industry.

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Documentation FDA Packaging Communication 52

The Thyroid Pharmacist

NOVEMBER 8, 2024

A new test is being developed for MAP detection in support of a vaccine for Crohn’s disease; it has been in clinical trials, and looks very promising. Researchers found they could suppress the autoimmune response if using a vaccine or antibiotic that specifically eradicates E. doi:10.1055/s-2008-1063667. [69] gallinarum. [55]

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Immunization Adverse Reactions Vaccines Hospitals 72