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FDA publishes long-awaited clinical trial diversity guidance

The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” which outlines the...more

Center for Clinical Trial Innovation furthers FDA’s diversity goals, rare disease drug development - Pilot program offers...

The U.S. Food and Drug Administration (FDA) has announced the establishment of the “Center for Drug Evaluation (CDER) Center for Clinical Trial Innovation” (C3TI). C3TI is intended to be a “central hub” within CDER aimed at...more

FDA and OHRP publish draft guidance on facilitating understanding in informed consent

As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of...more

How to use a Data Monitoring Committee in clinical trials: FDA invites industry comment

Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in Clinical Trials.” In the...more

FDA updates 2016 guidance on the collection of race and ethnicity data

The U.S. Food and Drug Administration (FDA) continues its efforts to include diverse participants in clinical research with a newly-published revision to its draft guidance document entitled, “Collection of Race and Ethnicity...more

FDA permits IRB informed consent waivers for minimal risk clinical trials

The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,” which permits an exception from the...more

FDA clinical trial diversity workshop reveals agency’s expectations for sponsors

On November 29 and 30, the U.S. Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative, hosted a public workshop on ways to increase the enrollment of historically...more

Informed consent duties for IRBs, investigators, and sponsors detailed in FDA final guidance

Nine years after the draft version was published, the Food and Drug Administration (FDA) has finalized its guidance on informed consent for sponsors, institutions, IRBs, and investigators. The final guidance supersedes FDA’s...more

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

Getting START’ed: New FDA programs aim to advance drugs to treat rare diseases

On September 29, 2023, the U.S. Food and Drug Administration (FDA or "agency") announced the opportunity for a limited number of sponsors to participate in a new pilot program called Support for clinical Trials Advancing Rare...more

Clinical trial diversity data can be boosted post-approval, FDA guidance explains

Continuing the trend over the past few years to promote diversity in clinical trials, the U.S. Food and Drug Administration (FDA) has published new draft guidance on “Postmarketing Approaches to Obtain Data on Populations...more

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

FDA draft clinical trial guidance promotes decentralized studies, digital tech use - GCP guidance comes ahead of FDA DCT webinar

Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance on Good Clinical Practice (GCP), adopting the International Council for Harmonisation’s (ICH) “E6(R3)” guidelines. Below we summarize how the draft...more

FDA proposes mandatory patient labeling for Rx drugs - Proposed Patient Medication Information (PMI) is the latest in many efforts...

Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the agency’s prescription drug product labeling...more

FDA issues milestone draft guidance on decentralized clinical trial design & implementation

The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices. In the draft...more

FDA authority to conduct bioresearch monitoring inspections expanded by appropriations legislation

U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act (FDORA). Below we analyze how Section 3612 of FDORA,...more

Homeopathic drug product makers warned to follow FDA premarket and GMP rules

Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against homeopathic products that it...more

Modernization of U.S. cosmetics regulation will be phased in over time - A detailed overview and preliminary analysis of the new...

On December 29, 2022, U.S. President Biden signed into law the "Consolidated Appropriations Act, 2023," which includes the Modernization of Cosmetics Regulation Act of 2022 (MOCRA). MOCRA reflects the most significant...more

FDA pushes OTC switch for naloxone, continuing trend toward making more drugs available without a prescription

The U.S. Food and Drug Administration (FDA) recently issued the Federal Register notice “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use,” which aims to help facilitate the...more

FDA explains how to use secondary endpoints in clinical trials to show efficacy

The U.S. Food and Drug Administration (FDA) recently finalized the guidance “Multiple Endpoints in Clinical Trials,” which advises drug sponsors on how to separate analyses of primary endpoints – which are critical to showing...more

Seeking harmony: FDA to align its human subject research regulations with Common Rule Some divergence between the regulations...

Recently, the U.S. Food and Drug Administration (FDA) released two proposed rules that aim to clarify inconsistencies between FDA’s human subject protection regulations and the Federal Policy for the Protection of Human...more

“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

FDA offers new guidance on charging for investigational drugs

On Monday, the U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Charging for Investigational Drugs Under an IND: Questions and Answers,” which responds to FAQs about FDA’s policies for charging...more

FDA may permit Rx-to-OTC switch using additional conditions beyond traditional labeling

On June 27, the U.S. Food and Drug Administration (FDA) published the long-awaited proposed rule “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (ACNU), which would could expand the...more

FDA invites comment on guidance on meetings with OTC sponsors

Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,” regarding formal meetings between FDA and meeting...more

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