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

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

Agency IQ

Second, as the life sciences industry well knows, the FDA is funded in part by user fees that are paid by industry, rather than by fully by federal appropriations. Per Gottlieb’s testimony before Congress in 2019 (see a Senate report here ), the agency’s field staff conducted “high risk” inspections, but paused routine inspections.

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

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 to include devices.

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

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. That would leave 19% of staff affected by furloughs. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

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

Agency IQ

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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

Agency IQ

Comments on LDT Proposed Rule: On December 4, the comment period on the FDA’s Laboratory Developed Test proposed rule will close, and we will get a fuller picture of the extent to which the life sciences industry opposes the FDA’s proposal. This is already proving to be one of the FDA’s most-opposed actions in years.

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