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Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Agency IQ

Notably, shutdowns can be either total or partial – as noted above, there are 12 appropriations bills, and if a subset of those bills are passed then only those agencies and Departments without an appropriations package will shut down (partial shutdown). history was in 2018-2019, totaling 35 days. The longest shutdown in U.S.

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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94

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Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs. to include devices.

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs. to include devices.

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Analysis Chemical Thank You Overview of the U.S. regulation of PFAS

Agency IQ

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.

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FDA Returns Disappointing News for ALS Stem Cell Therapy

PLOS: DNA Science

One widely-quoted study that investigated nearly 20,000 professional football players who had participated in at least one game between 1960 and 2019 revealed a four-fold elevated risk of developing ALS compared to the general population. The disease may develop in response to an environmental factor, such as repeated head injuries.

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The Pharma Data

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