FDA Law Blog: Biosimilars

APRIL 8, 2024

FDA previously analyzed 163 drugs that went into shortage in the 5-year period between 2013 and 2017; 63% (103) were sterile injectables and 67% (109) were drugs that have a generic version on the market. of the White Paper states, accurately, that “factors that cause drug shortages are multi-faceted and involve many market participants.”

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Agency IQ

JUNE 16, 2023

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. The rule, will also, if finalized, address communication with State boards of pharmacy. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

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Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

OCTOBER 27, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

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Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

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Drug & Device Law

JULY 24, 2023

The drug is still on the market, and it has other risks that the FDA has found significantly more serious – requiring a boxed warning – than a three-one hundredths-of one-percent (0.0003) increase in absolute incidence of bladder cancer. the relationship between [plaintiff] and its pharmacy benefit manager. . . 555, 565 (E.D.

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Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth Laboratories, Inc. , 2d 839, 851 (N.Y.

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