Lisa Dwyer on Manufacturers

Nearly a Century in the Making: Congress Modernizes FDA’s Regulation of Cosmetics

The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more

1/10/2023 / Animal Testing , Asbestos , Cosmetics , Distributors , Draft Guidance , EU , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Act , Food and Drug Administration (FDA) , Labeling , Manufacturers , New Regulations , PFAS , Product Recalls , Product Safety Labels , Suspensions

FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance

On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more

12/20/2022 / Citations , Draft Guidance , FDARA , FDASIA , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Inspections , Manufacturers , Medical Devices , OSHA , Pharmaceutical Industry , Prescription Drugs

Act II: The Senate Unveils Its Draft

On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more

6/2/2022 / Animal Testing , BsUFA , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , DSHEA , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , GDUFA , HELP , Manufacturers , Medical Device User Fee Program (MDUFA IV) , PDUFA , PFAS , Prescription Drugs , Public Health , Public Health Service Act , Purple Book , REMS , Title III

2019 Year in Review: FDA Office of Prescription Drug Promotion

In 2019, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of ten enforcement letters targeting advertising and promotion violations for prescription drugs. Of the ten...more

3/2/2020 / Food and Drug Administration (FDA) , Manufacturers , Off-Label Promotion , OPDP , Pharmaceutical Industry , Prescription Drugs , Warning Letters

FDA FY 2021 Budget Foretells Medical Device Cybersecurity Reform

Increased premarket submission and post-market reporting requirements potentially on the horizon for high-tech devices. The Food and Drug Administration’s (“FDA’s”) budget proposal for FY2021 telegraphs FDA’s plan to seek new...more

2/25/2020 / Cybersecurity , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Regulatory Reform , Reporting Requirements , Risk Management , Rulemaking Process

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

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 and Life Sciences FDA Finalizes Guidances for “Consistent Communications” and Payor Communications

A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more

6/21/2018 / Final Guidance , First Amendment , Food and Drug Administration (FDA) , HCEI , Labeling , Life Sciences , Manufacturers , Medical Devices , Off-Label Use , Pharmaceutical Industry , Prescription Drugs , Required Communications , Safe Harbors

FDA Issues Draft Guidance Addressing Communications with Payors

On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more

1/23/2017 / 21st Century Cures Act , Draft Guidance , FDAMA , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , HCEI , Investigational New Drug Application (IND) , Manufacturers , Material Dissemination , Payor Contracts , Safe Harbors , Section 502

FDA Takes Action in the Last Days of the Obama Administration to Clarify Some of Its Views on Off-Label Communications

In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more

1/20/2017 / Food and Drug Administration (FDA) , Health Care Providers , Labeling , Manufacturers , Obama Administration , Off-Label Use

FDA Launches Form for Reporting Allegations of Misconduct by Device Manufacturers

Program Has Broad Reach - On October 21, 2016, the Food and Drug Administration launched a webpage that contains an Allegations of Regulatory Misconduct Form to enable whistleblowers, competitors, and others to report...more

11/1/2016 / Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Willful Misconduct

Lisa Dwyer

King & Spalding

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