Kathryn Armstrong on Food and Drug Administration (FDA)

The Establishment of the White House Gender Policy Council and Its Implications for FDA Initiatives and Priorities

On March 8, 2021, President Biden signed an Executive Order, establishing a Gender Policy Council (“the Council”) tasked with the broad policy goal of “advancing gender equity and equality” for the purpose of reducing...more

3/16/2021 / Biden Administration , Clinical Trials , Coronavirus/COVID-19 , Executive Orders , Food and Drug Administration (FDA) , Gender Equity , Secretary of HHS

FDA Finalizes Rule and Guidance to Implement Safe Importation Action Plan Aimed at Lowering Prescription Drug Prices

On September 24, 2020, FDA announced that it was taking action to help lower prescription drug prices by issuing a final rule and a final guidance aimed at facilitating the safe importation of certain prescription drugs....more

10/5/2020 / Canada , Department of Health and Human Services (HHS) , DSCSA , Executive Orders , Final Guidance , Final Rules , Food and Drug Administration (FDA) , Health Care Providers , Hospitals , Pharmacies , Pharmacist , Prescription Drugs

FDA Proposes New Rule Modifying its “Intended Use” Regulations

Yesterday, FDA published a proposed rule amending its medical product “intended use” regulations in an effort to “provide direction and clarity to regulated industry and other stakeholders.” If finalized, the rule would amend...more

9/25/2020 / Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Intended Use , Pharmaceutical Industry , Proposed Rules

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

FDA’s Focus on Devices Impacting Women’s Health is Fully Underway: Breast Implant Advisory Set for March 25-26

Late last year, the Food and Drug Administration’s (FDA’s) Device Center announced a new objective when it comes to devices – “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and...more

2/22/2019 / Advisory Committee , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Life Sciences , Manufacturer Liability , Manufacturers , Medical Devices , Pharmaceutical Industry

FDA Announces “Modernization” Reforms to Medical Device Review Process

FDA Announces Intent to Modernize the Medical Device Review Process that Would Discourage Reliance on Older Devices as Predicates for the 510(k) Process - Last week FDA released two statements announcing plans and...more

12/4/2018 / 510(k) RTA , Food and Drug Administration (FDA) , Medical Devices , National Evaluation System for Health Technology (NEST)

Kathryn Armstrong

King & Spalding

Popular Topics by This Author

Latest Posts › Food and Drug Administration (FDA)

The Establishment of the White House Gender Policy Council and Its Implications for FDA Initiatives and Priorities

FDA Finalizes Rule and Guidance to Implement Safe Importation Action Plan Aimed at Lowering Prescription Drug Prices

FDA Proposes New Rule Modifying its “Intended Use” Regulations

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

FDA’s Focus on Devices Impacting Women’s Health is Fully Underway: Breast Implant Advisory Set for March 25-26

FDA Announces “Modernization” Reforms to Medical Device Review Process

Kathryn Armstrong

King & Spalding

Popular Topics by This Author

Latest Posts › Food and Drug Administration (FDA)

The Establishment of the White House Gender Policy Council and Its Implications for FDA Initiatives and Priorities

FDA Finalizes Rule and Guidance to Implement Safe Importation Action Plan Aimed at Lowering Prescription Drug Prices

FDA Proposes New Rule Modifying its “Intended Use” Regulations

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

FDA’s Focus on Devices Impacting Women’s Health is Fully Underway: Breast Implant Advisory Set for March 25-26

FDA Announces “Modernization” Reforms to Medical Device Review Process

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