FDA Law Blog

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. FDA extended PMTA compliance deadlines for years so it could figure out appropriate application instructions and so that manufacturers could figure out how to comply.

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Manufacturing IT Provider ER 115

FDA Law Blog

MARCH 6, 2024

His presentation will focus on “MoCRA is Here – Now What? Featuring speakers from the USPTO, FTC, FDA, distinguished members of the Judiciary, and in-house and outside counsel, HP&M Director Kurt Karst will be a presenter at the 20th Annual Paragraph IV Disputes Conference , April 25 – 26 in New York, NY.

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Management Manufacturing Government Specialization 59

FDA Law Blog

OCTOBER 17, 2023

If you are developing such products, now may be the time to explore the opportunities presented by the Breakthrough Devices Program. FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations.

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Medical Diagnosis Healthcare Clinic 53

Tiny Physician

OCTOBER 17, 2021

The Kerala government has taken off all the restrictions imposed due to the case surge as caseload has come down, and is also planning to restart schools from the second half of November. Later, due to mass outrage from the scientific community, the label of ‘drug for treatment’ was changed to ‘immunity booster’ (5). References 1.

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Vaccination Government IT Physicals 52