Robert Friedman

King & Spalding

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Latest Posts › New Guidance

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FDA Releases Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol

On May 10, the U.S. Food and Drug Administration (“FDA”) released a new guidance document Guidance for Industry: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution,...more

5/22/2023 / Contamination , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , New Guidance , Pharmaceutical Industry , Public Health

New FDA Guidance on Control of Nitrosamine Impurities

FDA Releases Guidance on the Agency’s Understanding of Nitrosamine Impurities - On September 1, 2020, the U.S. Food and Drug Administration (“FDA”) released a new guidance document, Guidance for Industry: Control of...more

9/4/2020 / APIs , Food and Drug Administration (FDA) , New Guidance , Over The Counter Drugs (OTC) , Prescription Drugs , Risk Assessment , Toxic Chemicals

FDA Continues its Focus on Breast Implant Safety and Transparency with an Eye Toward Improving Regulatory Decision-Making

In an August 20, 2020, press release, the Food and Drug Administration (FDA) provided an update on the medical device reports (MDRs) received by the agency relating to breast implants, including breast implant-associated...more

9/1/2020 / Advisory Committee , Food and Drug Administration (FDA) , Medical Device Reports (MDRs) , Medical Devices , New Guidance , Transparency

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