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Compliance Delay on Cosmetic Registration

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Federal Register notice: FDA makes available a guidance entitled Compliance Policy for Cosmetic Product Facility Registration and ...

Former Reviewer McGarry Joins Greenleaf Health

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Former FDA reviewer Sarah McGarry joins consulting firm Greenleaf Health as senior vice president of drug and biological products.

Rexulti Ads False and Misleading: OPDP

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The CDER Office of Prescription Drug Promotion says two Otsuka Rexulti ads contain misleading presentations of the drugs efficacy....

Lilly Obesity Drug Gains FDA Approval

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FDA approves an Eli Lilly NDA for Zepbound (tirzepatide) subcutaneous injection for chronic weight management in obese adults who ...

Support for Convalescent Plasma Registries

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CBER director Peter Marks and three medical center researchers editorialize on the value of registries to promote convalescent pla...

Organon Backs FDA Biosim Label Change

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Organon says it agrees with an FDA policy change to have a biosimilar statement accompany both biosimilars and interchangeables.

Democrats Introduce Anti Pay-for-Delay Bill

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Reps. Marie Gluesenkamp Perez (D-WA), Sean Casten (D-IL), and Gerry Connolly (D-VA) introduce a bill to ban brand companies from e...

Guide on Real-Time Oncology Reviews

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Federal Register notice: FDA makes available a guidance entitled Real-Time Oncology Review (RTOR).

14 Observations in Kilitch India FDA-483

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FDA releases the form FDA-483 with 14 observations from an inspection at the Kilitch Healthcare India sterile drug manufacturing f...

FDA Proposes to Withdraw Carbadox Approval

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Federal Register notice: FDA proposes to withdraw approval of Phibro Animal Healths NADAs for carbadox in medicated swine feed.