Bridgette Keller on Food and Drug Administration (FDA)

Health Law Diagnosed – Best Practices for Communicating with the FDA

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA....more

7/10/2025 / Best Practices , Clinical Trials , Compliance , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Regulatory Agencies , Regulatory Requirements

[Podcast] Health Law Diagnosed – Best Practices for Communicating with the FDA

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more

7/9/2025 / Best Practices , Clinical Trials , Compliance , Enforcement Actions , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements

Health Law Diagnosed – A Discussion on the Regulatory Requirements for LDTs

In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory...more

3/11/2024 / Clinical Laboratories , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Pharmaceutical Industry , Proposed Rules

OIG Says that Increasing Use of Biosimilars Could Reduce Part D Spending

Last month, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a report finding that Medicare Part D, and Medicare beneficiaries, could reduce spending with increased use of...more

5/3/2022 / Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Medicare Part D , OIG , Out-of-Pocket Expenses

Bioethics in a Pandemic: FDA Guidance on Granting EUAs for a COVID-19 Vaccine

Earlier this month, the FDA’s Center for Biologics Evaluation and Research issued its highly anticipated guidance outlining the agency’s current thinking on granting emergency use authorization (EUA) to investigational...more

10/29/2020 / Biologics , CARES Act , Centers for Medicare & Medicaid Services (CMS) , Clinical Trials , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Infectious Diseases , Interim Final Rules (IFR) , Investigational New Drug Application (IND) , Proposed Rules , Provider Relief Fund , Public Health Emergency , Vaccinations

The Contraception Coverage Controversy Continues…

As we have been discussing, the Affordable Care Act (“ACA”) requires all health plans to cover preventive health services for women, including all Food and Drug Administration (“FDA”)-approved contraceptives, at no cost (i.e....more

10/31/2014 / Affordable Care Act , Burwell v Hobby Lobby , Contraceptive Coverage Mandate , Contraceptives , Department of Health and Human Services (HHS) , Department of Labor (DOL) , Employer Mandates , First Amendment , Food and Drug Administration (FDA) , Religious Exemption , Religious Freedom Restoration Act (RFRA) , SCOTUS

Government Issues New Rules for Religious Employers, But Health Plans, TPAs, and PBMs are still on the Hook to Provide...

The Affordable Care Act (“ACA”) requires that non-grandfathered health plans make preventive care and screenings available to their members at no cost (i.e. no deductibles, coinsurance, or co-payments). The Department of...more

9/4/2014 / Affordable Care Act , Contraceptive Coverage Mandate , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Healthcare , Religion , Religious Exemption , TPAs

Notice to Plans and PBMs: Pay for Contraceptive Services and Maybe We Will Pay You Back

As has been widely covered in the news, regulations and guidance developed under the Affordable Care Act (“ACA”) require that non-grandfathered health plans make preventive care and screenings available to their members at no...more

2/18/2014 / Affordable Care Act , Benefit Plan Sponsors , Contraceptive Coverage Mandate , Contraceptives , Department of Health and Human Services (HHS) , Employee Benefits , Food and Drug Administration (FDA) , Healthcare

Bridgette Keller

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