Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

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Agency IQ

JUNE 16, 2023

FDA’s is generally consistent from edition to edition , will each edition consisting primarily of holdovers from previous editions. The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. Read our analysis of that rule here and here. ]

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Regulations FDA Science Production 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. November is packed with regulatory and industry meetings. to include devices.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The December calendar is packed with regulatory and industry meetings.

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FDA Science Regulations Production 40

Drug & Device Law

FEBRUARY 11, 2024

Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v. Longbons T., Harrison D.J.,

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FDA Production FDA Approval Regulations 59

Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. They excluded bogus expert testimony under Fed. As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. Bonta , 85 F.4th

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Testimonials FDA Drugs Vaccine 105

Drug & Device Law

DECEMBER 21, 2023

There’s no science to back any of the allegations up – as demonstrated by the masterful (and even longer) take down of nearly identical substantive allegations in the Zantac ( 2022+4 ) MDL. The FDA, for one, advised patients to keep using these drugs. Valsartan , by contrast, responds with platitudes and 50,000 foot generalizations.

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FDA Approval FDA Drugs Production 52