Maarika Kimbrell on Clinical Trials

Conditional Approval Proposals for FDA: Current Context and Potential Ramifications

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a perennial focus of stakeholders...more

5/1/2025 / Clinical Trials , Drug Pricing , Food and Drug Administration (FDA) , New Regulations , Patient Access , Pharmaceutical Industry , Prescription Drugs , Public Health , Regulatory Reform

FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers

The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more

4/7/2025 / Biotechnology , Clinical Trials , Drug Pricing , Food and Drug Administration (FDA) , New Guidance , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Regulatory Reform , Regulatory Requirements

Clinicaltrials.gov: Recent Action May Signal Increased Attention from FDA on Trial Data Reporting Compliance

The US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice...more

1/28/2025 / Civil Monetary Penalty , Clinical Trials , Disclosure Requirements , Enforcement Actions , Food and Drug Administration (FDA) , Food and Drug Administration Amendments Act (FDAAA) , Reporting Requirements , Securities and Exchange Commission (SEC)

Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead

With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be no exception to this rule, and with its arrival we examine FDA’s activities...more

1/20/2025 / Biologics , Clinical Trials , Food and Drug Administration (FDA) , Hatch-Waxman , Life Sciences , Pharmaceutical Industry , Popular , Prescription Drugs , Regulatory Requirements

A Bevy of Recent FDA Updates on Innovation in Clinical Trial Design

Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration...more

10/1/2024 / Clinical Trials , Food and Drug Administration (FDA) , Life Sciences , Medical Research , Pharmaceutical Industry , Prescription Drugs

FDA Issues Long-Awaited Diversity Action Plan Guidance

Recognizing the importance of diversity and inclusivity in clinical trials, drug development, and regulatory decision-making, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) in connection with the Food and...more

8/19/2024 / Clinical Trials , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Prescription Drugs

Key Issues for Life Science Executives for 2024: JP Morgan Healthcare Conference Takeaways

It is hard to believe that we are already in February and it has been a month since the 42nd Annual JP Morgan Healthcare Conference in San Francisco wrapped. It was a packed four days in which the major players in the life...more

2/15/2024 / Biologics , Clinical Trials , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Prescription Drugs

Pharma’s Almanac: Forecast at the Turn of the Year

The ball has dropped on the healthcare and life sciences industry’s unique New Year tradition, the J.P. Morgan Healthcare Conference, so all eyes turn to 2024. To help define a path forward, Morgan Lewis FDA and healthcare...more

1/22/2024 / Biologics , Clinical Trials , FDA Approval , Life Sciences , Pharmaceutical Industry , Prescription Drugs

2023 Drugs and Biologics Year in Review: Will FDA's 2023 Evolution Usher in Swift Resolutions for 2024?

The US Food and Drug Administration (FDA) was busy in 2023 with significant, and even bullish, developments occurring across several areas, from drug and biologic development and manufacturing to labeling, advertising, and...more

1/10/2024 / Biologics , Biosimilars , Clinical Trials , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Prescription Drugs

Maarika Kimbrell

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