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

Agency IQ

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 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.

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

Agency IQ

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 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.

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

Agency IQ

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025. to include devices.

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

Agency IQ

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 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 include devices.

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

Agency IQ

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 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 include devices.

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Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

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No Expert Do-Overs

Drug & Device Law

In re Zoloft Products Liability Litigation , 2015 WL 115486 (E.D. In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation , 2015 WL 7776911 (E.D. Plaintiffs will not be heard to argue that they “could have shored up their cases by other means had they known their expert testimony would be found inadmissible.”