-
Apr 19, 2024 | 
jdsupra.com | Steve Abrams |Lynn Mehler |Jane Summerfield
While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent regulatory changes and those on the horizon will impact supply chain planning, commercial launch preparation, and pricing and reimbursement, making a cross-border perspective even more critical for achieving long term business goals.
Please see full publication below for more information.
-
Mar 22, 2024 | 
jdsupra.com | Sally Gu |Katie Kramer |Lynn Mehler
For the purpose of this draft guidance, FDA defines a non-interventional study as a study in which patients receive the marketed drug of interest during routine medical practice and are not assigned to an intervention according to a protocol.
-
Jan 29, 2024 | 
jdsupra.com | Lynn Mehler |Will Tenbarge
January 29, 2024
To embed, copy and paste the code into your website or blog:
Enacted in December 2019 as part of the Further Consolidated Appropriations Act of 2020, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (21 USC 355-2) addresses concerns that some brand manufacturers improperly restricted access to their products.
-
Jun 30, 2023 | 
cannabislaw.report | Stephanie Agu |David Fox |Lynn Mehler
Source JD Suprahttps://www.jdsupra.com/legalnews/new-fda-guidance-on-psychedelic-drug-4106424/Stephanie Agu,David Fox,Lynn MehlerHogan LovellsOn Friday, the U.S. Food and Drug Administration (FDA) published thedraft guidance“Psychedelic Drugs: Considerations for Clinical Investigations,” which outlines the foundational constructs for investigating the therapeutic potential of these compounds.
-
Jun 27, 2023 | 
jdsupra.com | Stephanie Agu |David Fox |Lynn Mehler
Interest in the therapeutic potential of psychedelic drugs has a long history across the globe. More recently, pharmaceutical companies, researchers, and academics have been evaluating the transformative potential of psychedelics through the pharmaceutical development pathway.
-
Jun 26, 2023 | 
lexology.com | Lynn Mehler |David Fox |Stephanie Agu
On Friday, the U.S. Food and Drug Administration (FDA) published the draft guidance “Psychedelic Drugs: Considerations for Clinical Investigations,” which outlines the foundational constructs for investigating the therapeutic potential of these compounds. Below we summarize these special considerations for clinical studies of psychedelic drugs, including CMC compliance, nonclinical research, assessment of the substance’s abuse potential, and other clinical research issues.
-
Jan 31, 2023 | 
jdsupra.com | Sally Gu |Lynn Mehler |Blake Wilson
The U.S. Food and Drug Administration (FDA) has several programs available that can expedite the development and regulatory review of a drug or biological product, including Accelerated Approval, which allows for approval of a drug or biologic based on surrogate or intermediate clinical endpoints while requiring the sponsor to develop additional clinical data postmarket to confirm efficacy.
-
Jan 31, 2023 | 
jdsupra.com | Sally Gu |Lynn Mehler |Eva Schifini
In an official statement last week, the U.S. Food and Drug Administration (FDA) announced its conclusion that the existing regulatory framework for foods and dietary supplements is not appropriate for the regulation of certain products containing cannabidiol (CBD). In the same statement, FDA invited Congress to create a new regulatory pathway for such CBD products.
-
Jan 31, 2023 | 
lexology.com | Lynn Mehler |Blake Wilson |Sally Gu
The U.S. Food and Drug Administration (FDA) has several programs available that can expedite the development and regulatory review of a drug or biological product, including Accelerated Approval, which allows for approval of a drug or biologic based on surrogate or intermediate clinical endpoints while requiring the sponsor to develop additional clinical data postmarket to confirm efficacy.
-
Jan 31, 2023 | 
lexology.com | Lynn Mehler |Sally Gu |Eva Schifini
In an official statement last week, the U.S. Food and Drug Administration (FDA) announced its conclusion that the existing regulatory framework for foods and dietary supplements is not appropriate for the regulation of certain products containing cannabidiol (CBD). In the same statement, FDA invited Congress to create a new regulatory pathway for such CBD products.
