The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease drugs and biologics to be...more
7/31/2025
/ Biotechnology ,
Clinical Trials ,
Drug Approvals ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Innovation ,
Medicare ,
New Legislation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
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
With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts...more
The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials...more
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
After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft Informed Consent Information Sheet...more
FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of the draft guidance is to modernize...more
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more
7/1/2020
/ Biologics ,
Biosimilars ,
CGMP ,
Clinical Trials ,
Coronavirus/COVID-19 ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Requirements ,
Research and Development
With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact...more
As the coronavirus (COVID-19) pandemic continues to grow, the US Food and Drug Administration (FDA) on March 18 issued a guidance document titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19...more
The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more
3/16/2020
/ Biotechnology ,
Center for Drug Evaluation and Research (CDER) ,
China ,
Clinical Trials ,
Contingency Plans ,
Coronavirus/COVID-19 ,
Crisis Management ,
Food and Drug Administration (FDA) ,
Imports ,
Infectious Diseases ,
Life Sciences ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Public Health ,
Supply Chain
The federal bill was signed into law on May 30 by the president, and will present new opportunities and challenges to clinical trial sponsors and healthcare entities....more