Sally Gu on Prescription Drugs

Reshoring EO aims to streamline permitting, approval, and oversight of US drug manufacturing

On May 5, 2025, President Donald Trump signed an Executive Order (EO) aiming to promote American-made prescription drugs (“Reshoring Manufacturing EO”). The EO directs federal agencies to eliminate regulatory hurdles,...more

5/8/2025 / Executive Orders , Food and Drug Administration (FDA) , Government Agencies , Investment , National Security , Pharmaceutical Industry , Prescription Drugs , Regulatory Reform , Regulatory Requirements , Supply Chain

How Trump’s reshoring EO affects plans to build or expand a domestic drug manufacturing facility

Investments in new (“greenfield”) or expanded (“brownfield,” “retrofit”) domestic manufacturing capabilities require years of strategic planning and capital expenditure. Even with the announcement of near-term incentives and...more

5/8/2025 / Construction Project , Drug Pricing , Executive Orders , Life Sciences , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements , Supply Chain , Trump Administration

FDA Finalizes Guidance for Communications About Unapproved Uses to HCPs, Clarifying Multiple Standards

The U.S. Food and Drug Administration (FDA) has published final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU...more

1/22/2025 / Food and Drug Administration (FDA) , Health Care Providers , Marketing , Medical Devices , Pharmaceutical Industry , Prescription Drugs

FDA advises on RWE non-interventional study use as evidence of effectiveness or safety

Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which provides recommendations to...more

3/22/2024 / Biologics , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Prescription Drugs

Inside the FDA Advanced Manufacturing Technologies Designation Program

On Tuesday, the U.S. Food and Drug Administration (FDA) launched a new program for entities using or developing advanced manufacturing technologies that is intended to expedite development and assessment of applications for...more

12/18/2023 / Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Pharmaceutical Industry , Prescription Drugs

FDA broadens scope on communication about unapproved uses to HCPs

The U.S. Food and Drug Administration (FDA) published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU...more

10/26/2023 / Food and Drug Administration (FDA) , Health Care Providers , Pharmaceutical Industry , Prescription Drugs

FDA concern over misleading DTC promotions increasing, new guidance suggests

The U.S. Food and Drug Administration (FDA) has finalized its 2018 draft guidance on “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements,” which offers...more

7/6/2023 / Direct to Consumer Sales , Food and Drug Administration (FDA) , Labeling , Prescription Drugs

“Advancing Real-World Evidence Program” offers drug sponsors early FDA meeting opportunity

FDA has announced the Advancing Real-World Evidence (RWE) Program, which aims to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in support of labeling for effectiveness...more

11/7/2022 / Biologics , Biosimilars , Disclosure Requirements , Food and Drug Administration (FDA) , Prescription Drugs , User Fees

Meta ban on health-targeting ads will soon restrict clinical trial recruiters

A new ban on “Detailed Targeting” options for advertisers on Facebook and other Meta-owned social media platforms – which includes restricting marketing based on “health causes” – takes effect January 19, and may make it more...more

1/12/2022 / Advertising , Clinical Trials , Facebook , Life Sciences , Pharmaceutical Industry , Prescription Drugs , Social Media , Standard Operating Procedures , Targeted Digital Advertising , Telehealth

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