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Form 10-K Evofem Biosciences, Inc. For: Dec 31

Form 10-K Evofem Biosciences, Inc. For: Dec 31
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Delaware , United-states , San-diego , California , Walnut-creek , Japan , Nigeria , Ukraine , Spain , Miami , Florida , Mississippi

FDA Roundup: November 28, 2023

FDA Roundup: November 28, 2023
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Connecticut , United-states , Jill-furman , Peter-marks , Daniel-jernigan , Jaqueline-corrigan-curay , International-medical-device-regulators-forum , Global-harmonization-working-party , Office-of-media-affairs , Springworks-therapeutics-inc , Office-of-compliance , Drug-administration

FDA Roundup: November 28, 2023

/PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a drug...

Connecticut , United-states , Daniel-jernigan , Jill-furman , Peter-marks , Jaqueline-corrigan-curay , Springworks-therapeutics-inc , Office-of-media-affairs , Office-of-compliance , Drug-administration , National-center , Global-harmonization-working-party

FDA Protects Patients from Harmful Drugs Through the Drug Supply Chain Security Act

The FDA has been working to implement the DSCSA since it became law, and the 10-year anniversary is a good time to recognize our work with industry and other stakeholders thus far and the initiatives in store for the future.

Jaqueline-corrigan-curay , Jill-furman , Office-of-the-center , Pilot-project-program , Office-of-compliance , Drug-administration , Center-director , Drug-evaluation , Drug-supply-chain-security-act , Drug-supply-chain-security , Project-program , Implement-supply-chain

Will the Feds Classify Marijuana as a "Safe" Drug?

Will the Feds Classify Marijuana as a "Safe" Drug?
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Denmark , Mexico , United-states , China , North-carolina , Washington , Russia , New-york , White-house , District-of-columbia , Danish , Brown-crouppen

First CRISPR therapy one step closer to approval

The big question is whether FDA advisers will favor additional studies, and if so, whether they should be conducted before or after approval.

United-states , White-house , District-of-columbia , American , Sarah-ryan , William-blair , Karine-jean-pierre , Brian-king , Joe-biden , John-obrien , Frederick-isasi , Chelsea-cirruzzo

Let the funding wars begin

The House is slated to consider legislation later this week funding the FDA and the Department of Agriculture for fiscal 2024.

Mexico , White-house , District-of-columbia , United-states , New-york , Mexican , Joe-biden , Aziyo-biologics , Caitlin-emma , Marc-molinaro , Lina-khan , Jennifer-scholtes

Accelerating Rare disease Cures (ARC) Program Emerges as a Conduit for Empowering Rare Disease Stakeholders

The ARC Program strives to increase the number of treatments by promoting innovative scientific design, providing a deeper understanding of regulatory policies, and engaging with patients and their advocates, and other rare disease stakeholders.

Kerry-jo-lee , Office-of-translational-sciences , Office-of-new-drugs , Regulatory-aspects-of-rare-disease-drug-development , Division-of-rare-diseases , Rare-disease-drug-developers , Rare-diseases-team , Office-of-communications , Office-of-the-center , Rare-neurodegenerative-disease-grant-program , Drug-development-program , Drug-administration-center

MedCrypt and Stratigos Security Partner to Offer Specialized Penetration Testing and Security Assessments for Life-Saving Medical Devices

MedCrypt and Stratigos Security Partner to Offer Specialized Penetration Testing and Security Assessments for Life-Saving Medical Devices
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Mike-kijewski , Seth-carmody , Paulino-calderon , Michelle-thompson , Naomi-schwartz , Lukas-kuzmiak , Cybersecurity-program , Drug-administration , Office-of-the-center , Medcrypt-inc , Device-lab , Infrastructure-security-agency

Inside FDA's Response to Reagan-Udall Foundation Report: Spotlight on the Cross-Cutting and Regulation and Guidance Task Forces | Troutman Pepper

In this segment of our series evaluating FDA’s response to the Report, we review a subset of the Report’s recommendations and responses from two CTP Task Forces—Cross Cutting and...

Drug-administration , Udall-foundation , Guidance-task , Cutting-task , Office-of-the-center , Reagan-udall-foundation , Tobacco-products , Cross-cutting , Strategic-plan , Center-director ,