-
Jan 22, 2025 | 
jdsupra.com | Suzanne Friedman |Sally Gu |Komal Karnik Nigam
[co-author: Gabrielle Simeck]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 Guidance), which describes permitted dissemination of scientific information on unapproved uses (SIUU) of approved/cleared medical products by firms to healthcare providers (HCPs).
-
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For the purpose of this draft guidance, FDA defines a non-interventional study as a study in which patients receive the marketed drug of interest during routine medical practice and are not assigned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.
-
Dec 18, 2023 | 
jdsupra.com | Sally Gu |David Horowitz |Ted Lis
Advanced manufacturing technologies can help to expedite and accelerate scale manufacturing capacities, offer new solutions to address drug shortages, and increase supply chain resilience. The program is required by Sec.
-
Oct 26, 2023 | 
jdsupra.com | Kristin Zielinski Duggan |Heidi Forster Gertner |Sally Gu
Since 2009, FDA has been operationalizing the “scientific exchange” safe harbor by way of 1) its 2014 “Revised Draft Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses-Recommended Practices” often referred to as “Good Reprint Practices,” which permitted companies to disseminate certain publications about unapproved uses, and 2) the 2011 “Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information about Prescription...
-
Oct 26, 2023 | 
lexology.com | Sally Gu |Meredith Manning |Heidi Forster Gertner |Kristin Zielinski Duggan
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU Guidance), describing permissible dissemination of scientific information on unapproved uses (SIUU) of approved/cleared medical products by firms to health care providers (HCPs); in other words, certain “off-label” information.
-
Jul 6, 2023 | 
jdsupra.com | Heidi Forster Gertner |Sally Gu |Meredith Manning
In the new final guidance, FDA cemented its October 2018 recommendations for DTC promotional labeling and advertising, citing research showing the use of quantitative information, rather than qualitative terms (e.g., "most," "rare," or "common"), may allow consumers to form more accurate and precise perceptions of the information presented.
-
Jul 6, 2023 | 
lexology.com | Meredith Manning |Heidi Forster Gertner |Sally Gu
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 recommendations on how companies can best present quantitative efficacy and risk information in direct-to-consumer (DTC) promotional materials.
-
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.
