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Health Care Week In Review: HHS Selects the First 10 Drugs for Medicare Drug Price Negotiation | Alston & Bird

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and. ....

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AGG Food & Drug Newsletter - April 2021 | Arnall Golden Gregory LLP

Federal
Register notice finally announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for Fiscal Year 2021. As we discussed in a previous Bulletin, the CARES Act, among other things, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow FDA to assess and collect user fees from qualifying owners of OTC monograph drug facilities and qualifying submitters of OTC monograph order requests (OMORs). The fees are meant to support FDA in its OTC monograph drug activities, including inspections of facilities associated with such products. More >
Arbitration as an Alternative to the Backlogged Courts ....

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This Is Not A Drill . . . FDA Publishes Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021 | Arnall Golden Gregory LLP

On March 26, 2021, the Food and Drug Administration (FDA) issued a new
Federal
Register notice finally announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for Fiscal Year 2021.
1 As we discussed in a previous Bulletin, the CARES Act, among other things, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow FDA to assess and collect user fees from qualifying owners of OTC monograph drug facilities
2 and qualifying submitters of OTC monograph order requests (OMORs).
3 The fees are meant to support FDA in its OTC monograph drug activities, including inspections of facilities associated with such products. ....

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FDA Reissues OTC Monograph User Fees - Food, Drugs, Healthcare, Life Sciences

FDA Reissues OTC Monograph User Fees - Food, Drugs, Healthcare, Life Sciences
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HHS overturns plan to slap $14,000 fee on distilleries who helped combat COVID

HHS overturns plan to slap $14,000 fee on distilleries who helped combat COVID
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Question of the Day
Chicken Kitchen owner Julio Salazar, left, buys hand sanitizer from Chainbridge Distillery owner Bela Nahori in Oakland Park, Fla., on Tuesday, Aug. 11, 2020. The local distillery was given FDA approval to stop making spirits and instead make hand sanitizer . more >
By Stephen Dinan
-
The Washington Times
-
Friday, January 1, 2021
Facing an outcry, the Department of Health and Human Services overruled the Food and Drug Administration late Thursday and canceled plans to charge $14,000 fees on distilleries that rushed to make hand sanitizer to combat the coronavirus. ....

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