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Medical Devices

Expanded Indication for Abbott Heart Catheter

FDA approves an expanded ventricular tachycardia indication for Abbotts FlexAbility catheter.

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Human Drugs

M13A Bioequivalence Consensus Guideline

FDA publishes the International Council on Harmonization M13A guidance on bioequivalence for immediate-release solid oral dosage forms.

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Human Drugs

Positive Covid Test Requirement Lifted on 2 Therapeutics

FDA says two Covid-19 therapeutics can now be prescribed without having a positive test result showing Covid-19 infection when a physician suspects su...

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Federal Register

FDA Panel to Review 2 RSV Vaccines

Federal Register notice: FDA announces a 2/28 to 3/1 Vaccines and Related Biological Products Advisory Committee meeting to discuss two BLAs for respi...

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Human Drugs

No Justification for Lexicon Hearing: CDER

CDER says Lexicon has failed to justify its request for an agency hearing on the Centers refusal to approve the companys NDA for sotagliflozin to help...

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Human Drugs

CDER Planning 98 New, Revised Guidances for 2023

CDER releases its proposed 2023 guidance agenda showing 98 planned new and revised guidances in 18 categories.

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Human Drugs

Lyme Disease Drug Development Guidance

FDA publishes a draft guidance with recommendations about developing drugs for treating early Lyme disease as manifested by erythema migrans.

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Human Drugs

IBSA Recalls Some Tirosint-Sol Lots

FDA says IBSA Pharma is recalling 27 lots of Tirosint-Sol oral solution due to subpotency.

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Federal Register

NCTR Science Panel to Provide Update

Federal Register notice: FDA announces a 4/4-5 advisory committee meeting of the Science Advisory Board to the National Center for Toxicological Resea...

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Human Drugs

Pfizer Gains Expanded Ibrance Indication

Pfizer says it gained an expanded indication in late December for Ibrance (palbociclib) to include its use in combination with an aromatase inhibitor ...