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Oct 2, 2024 | 
jdsupra.com | Michael Druckman |Meredith Manning |Bryan Walsh
FDA’s regulations set forth criteria for determining when particular products are regulated merely as transplanted human cells or tissues subject only to the authority of Section 361 of the Public Health Service Act (PHSA) to prevent the transmission of communicable diseases. Such products, referred to as “361 HCT/Ps” or 361 products, may be sold without prior FDA review.
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Oct 2, 2024 | 
lexology.com | Meredith Manning |Bryan Walsh |Mike Druckman
The U.S. Court of Appeals for the Ninth Circuit on Friday reversed the district court’s judgment in United States v. California Stem Cell Treatment Center, siding with the U.S. Food and Drug Administration (FDA) in finding that a stem cell clinic’s stromal vascular fraction (SVF) products may be regulated by the agency as new drugs.
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Sep 1, 2024 | 
bizjournals.com | Meredith Manning
Over the past year, St. Anthony’s partnered with notable leaders who are raising the bar on service, advocacy and collaboration with impressive results. Some 70 years ago, a quiet, compassionate friar found a way to feed hundreds of vulnerable San Franciscans in a modest Tenderloin dining room where hope and health were in short supply. Father Alfred Boeddeker welcomed men and women inside without judgment — just free meals and friendship in a warm, dignified setting.
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Feb 6, 2024 | 
donate.coloncancercoalition.org | Rachael A. Mintz-Cole |Meredith Manning |Tali Highsmith |Larry Hotdogs
Join us for the second from 5:00-11:00pm to kick off the weekend events. 3:00 - 5:00 p.m. - Runs for Buns pick up in group sales. 8:00 p.m. - 9:00 a.m. to 5:00 p.m. - Runs For Buns. Participants will ski as many runs as possible using lift 5. There will be a special lift line designated for all participants. You must pass through the gate at lift 5 to register your RFID ticket.
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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The U.S. Food and Drug Administration (FDA) published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU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.
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Oct 6, 2023 | 
jdsupra.com | Meredith Manning |Randy Prebula |Jodi Scott
Back in 2018, the U.S. Food and Drug Administration published a proposed framework for regulating output of digital health tools accompanying prescription drugs as labeling. As we reported at the time, FDA introduced the term “prescription drug-use-related software”, defined as software disseminated by or on behalf of a drug sponsor that accompanies one or more of the sponsor’s prescription drugs (including biologics).
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Oct 5, 2023 | 
lexology.com | Meredith Manning |Randy Prebula |Jodi Scott
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software” (PDS Guidance), which describes how FDA intends to apply its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or a prescription drug-led (i.e., Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER)...
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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.
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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.
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Jun 7, 2023 | 
lexology.com | Meredith Manning |Heidi Forster Gertner |Lauren Colton |Julie Schindel |Bryan Walsh
Proposed Patient Medication Information (PMI) is the latest in many efforts by FDA to mandate patient-directed labelingLast 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 regulations to require that Rx drug and biological product applicants create a new type of Medication Guide, called the Patient Medication Information (PMI).
