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Advisory Committee

All articles tagged with #advisory committee

RFK Jr. reshapes FDA peptide panel as scientists warn on unproven drugs
health14 days ago

RFK Jr. reshapes FDA peptide panel as scientists warn on unproven drugs

Kennedy has packed the FDA’s Pharmacy Compounding Advisory Committee with peptide advocates and industry ties, even as FDA scientists warn that several popular injectable peptides lack proven safety or efficacy. The agency added nine new members (raising the panel to 13) who will review seven peptides and consider whether compounding pharmacies can produce them for human use, with final determinations expected after input from the advisory process.

via Ars Technica|
#advisory-committee#compounding-pharmacies#fda
Kennedy seeks FDA reconsideration of 12 unproven peptides amid safety concerns
health-policy2 months ago

Kennedy seeks FDA reconsideration of 12 unproven peptides amid safety concerns

The FDA announced July 2026 and February 2027 advisory meetings to consider restoring access to 12 unproven peptides previously removed from a compounding-drug list due to safety risks, despite no new supporting safety or efficacy data. RFK Jr. has championed these peptides, claiming the meetings will “restore science,” while critics warn the Pharmacy Compounding Advisory Committee is under-staffed and at risk of being populated by allies, potentially circumventing standard drug-approval scrutiny. The seven peptides to be reviewed in July are BPC-157, KPV, TB-500, MOTs-C, Emideltide (DSIP), Semax, and Epitalon; the five scheduled for February 2027 are Cathelicidin LL-37, GHK-Cu, Dihexa-acetate, Melanotan II, and Mechano Growth Factor PEG-MGF, all of which lack proven uses.

via Ars Technica|
#advisory-committee#fda#health-policy
Key Highlights and Controversies at the CDC Vaccine Advisory Meeting
health10 months ago

Key Highlights and Controversies at the CDC Vaccine Advisory Meeting

A US CDC vaccine advisory committee is set to meet and potentially make significant changes to the childhood vaccine schedule, amid controversy over new members appointed by vaccine skeptic Robert F. Kennedy Jr. The meeting will focus on COVID-19 vaccine recommendations, hepatitis B vaccination policies, and other immunization issues, with concerns about politicization and scientific integrity influencing the process.

via CNN|
#advisory-committee#cdc#covid-19
"Former GMs Bob Myers and Rick Spielman to Advise Commanders on Hiring New Coach After Firing Ron Rivera"
sports2 years ago

"Former GMs Bob Myers and Rick Spielman to Advise Commanders on Hiring New Coach After Firing Ron Rivera"

Commanders owner Josh Harris has announced the formation of a small advisory committee, including former Vikings GM Rick Spielman and former Golden State Warriors GM Bob Myers, to assist in the hiring of a new head coach and head of football operations following the firing of Ron Rivera. Harris emphasized the importance of finding the right candidates to lead the franchise forward after a challenging 4-13 season, acknowledging the significant rebuilding job ahead for the team.

via NBC Sports|
#advisory-committee#bob-myers#commanders
FDA Panel Supports Alnylam's Expanded Use of Gene Silencing Drug
healthcare2 years ago

FDA Panel Supports Alnylam's Expanded Use of Gene Silencing Drug

The FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9-3 in favor of Alnylam Pharmaceuticals' Onpattro for the treatment of ATTR cardiomyopathy, with panelists agreeing that the benefits outweigh the risks. While acknowledging the limited benefits, committee members expressed hope that clinicians would counsel patients on this treatment option.

via Endpoints News|
#advisory-committee#alnylam-pharmaceuticals#attr-cardiomyopathy
FDA Opposition Causes Sarepta Stock to Plummet.
business3 years ago

FDA Opposition Causes Sarepta Stock to Plummet.

Sarepta Therapeutics' shares fell after a report from STAT revealed that the FDA had planned to reject the company's application for approval of its gene therapy to treat Duchenne muscular dystrophy without holding an advisory committee meeting. However, Dr. Peter Marks, the top FDA official, intervened and scheduled the hearing, leading to uncertainty about the approval of the gene therapy.

via Barron's|
#advisory-committee#business#duchenne-muscular-dystrophy
Sarepta's Gene Therapy Faces FDA Setback, Stock Plummets.
business3 years ago

Sarepta's Gene Therapy Faces FDA Setback, Stock Plummets.

Sarepta Therapeutics' stock crashed nearly 20% after the FDA announced it would hold an advisory committee to discuss the risks and benefits of its gene therapy for Duchenne muscular dystrophy, despite the company's belief that it had met the requirements for accelerated approval. The FDA's decision to hold the advisory committee meeting before the May 29 approval decision date has raised concerns about a potential extension of the approval date. However, some analysts remain optimistic about the potential for Sarepta's gene therapy to ultimately gain approval.

via Investor's Business Daily|
#accelerated-approval#advisory-committee#business
San Francisco Board Shows Unanimous Support for $5 Million Reparations for Eligible Black Residents.
politics3 years ago

San Francisco Board Shows Unanimous Support for $5 Million Reparations for Eligible Black Residents.

San Francisco supervisors are considering paying reparations to Black people, but have not yet decided on the form of payment. The idea of Black reparations is not new, but movements began spreading across the country after George Floyd's death in 2020. Supporters argue that decades of racist policies and laws have systemically denied Black Americans access to property, education, and the ability to build generational wealth. Critics say it is not fair for municipal taxpayers to shoulder the cost of structural racism and discriminatory government policies. The advisory committee has made over 100 recommendations, including education, health, and job opportunities, but it is not clear how San Francisco will finance its atonement and repair.

via The Associated Press|
#advisory-committee#black-americans#politics