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Fda

All articles tagged with #fda

health5 hours ago•3 min saved

Class I Recall Issued for 55,000+ Pounds of Blueberries Over Listeria Risk

The FDA upgraded an Oregon Potato Company recall of about 55,689 pounds of IQF blueberries to Class I due to possible listeria monocytogenes contamination; the product was distributed to Michigan, Oregon, Washington and Wisconsin and not sold in retail stores; listeria can grow at refrigerator temperatures and cause listeriosis, with higher risk for pregnant women and their babies, older adults, and people with weakened immune systems; exposure should prompt contacting the FDA’s emergency line or submitting a MedWatch report.

via KGW|

#blueberries #fda #food-safety

health8 hours ago•3 min saved

Class I recall: 55k pounds of IQF blueberries flagged for listeria risk

FDA upgraded the recall of about 55,689 pounds of IQF blueberries from the Oregon Potato Company to Class I due to potential listeria monocytogenes contamination; the product was distributed to Michigan, Oregon, Washington and Wisconsin and not sold directly in retail stores. Listeria can grow at refrigeration temperatures and cause severe illness (listeriosis), especially in pregnant people, older adults, and those with weakened immune systems; the FDA urges anyone who may have become ill to contact 888-SAFEFOOD or file a MedWatch report.

via KING5.com|

#blueberries #class-i #fda

health1 day ago•2 min saved

FDA rolls out inaugural pathway for tailor-made rare-disease drugs

The FDA unveiled a new plausible mechanism pathway to approve medicines crafted for patients’ individual mutations, moving the idea from preview into formal policy and potentially enabling gene-editing–based and other targeted therapies for rare diseases.

via statnews.com|

#fda #gene-editing #health

health2 days ago•2 min saved

Pharma lobbying tightens its grip on the FDA as Trump politics enter the agency

STAT reports that the Trump administration is injecting political priorities into the FDA, signaling a shift from its historically insulated stance. Pharma lobbyists, advisers, and FDA insiders describe more routine interactions about agency decisions, a norm that critics say increases industry influence. Kennedy Jr. has pledged to root out such influence, but sources say the system is now more receptive to political and industry pressures.

via statnews.com|

#fda #health #health-policy

health2 days ago•14 min saved

FDA pitches faster path to rare-disease therapies

The FDA, led by Dr. Marty Makary in a White House event with President Trump, proposed a new framework to speed approvals for therapies targeting rare diseases.

via AP News|

#drug-approvals #fda #health

health-policy2 days ago•3 min saved

FDA Unveils Plausible Mechanism Framework to Accelerate Tailored Therapies for Ultra-Rare Diseases

The FDA issued a draft guidance outlining a Plausible Mechanism Framework to accelerate approvals of genome-editing and RNA-based, individualized therapies that target the root causes of ultra-rare diseases, allowing smaller, robust studies and the use of master protocols. Sponsors must demonstrate the therapy addresses the specific disease mechanism, rely on well-characterized natural history data, and show target engagement or editing; public comments are due within 60 days.

via fda.gov|

#fda #genome-editing #health-policy

health2 days ago•11 min saved

Patch Shortage Tests Access to Menopause Hormone Therapy

Rising demand for menopause hormone therapy—accelerated by FDA label changes and greater public awareness—is outpacing the supply of estrogen transdermal patches, leading to intermittent stockouts, patient brand-switching, and higher costs. Doctors are advising alternatives (other patches, gels, pills) and working with manufacturers to increase capacity as supply catches up.

via CNN|

#estrogen-patch #fda #health

health4 days ago•4 min saved

FDA eases 'no artificial colors' labeling amid dye safety debate

The FDA announced it will allow food makers to label products as "no artificial colors" even if dyes are still used, effectively retreating from a plan to ban artificial colorants; critics warn such labeling could mislead consumers and leave dangerous additives like titanium dioxide in foods, while supporters say it advances the shift toward safer, naturally derived alternatives. The move comes amid pressure from the Kennedy-led Maha movement and ongoing state actions, with health groups urging a permanent dye ban and continued scrutiny of both synthetic and natural colorants.

via The Guardian|

#artificial-colors #fda #food-dyes

health4 days ago•6 min saved

Psilocybin-based therapy shows rapid relief in treatment-resistant depression, eyeing FDA approval

Compass Pathways reported two positive late-stage trials of a synthetic psilocybin treatment that rapidly reduces symptoms in patients with treatment-resistant depression, potentially becoming the first psychedelic medicine to gain full regulatory approval if the FDA approves it early next year.

via The Economist|

#compass-pathways #depression #fda

health5 days ago•2 min saved

One-pivotal-trial rule aims to redefine drug approvals

FDA officials say a single pivotal trial will be the default standard for drug approvals, a policy shift outlined in an NEJM perspective by Marty Makary and Vinay Prasad.

via Endpoints News|

#drug-approvals #fda #health

public-health5 days ago•16 min saved

Immunization in the Crosswinds: Courts, States, and Agencies Reshape U.S. Vaccine Policy

This biweekly briefing maps sweeping shifts in U.S. vaccine policy: federal court battles over pediatric vaccine scheduling and ACIP governance, state efforts to roll back school vaccine requirements, regulatory reversals on Moderna’s mRNA flu vaccine, and a leadership shake-up at the CDC, all set against widening data gaps and new data tools from public health researchers and advocates.

via CIDRAP|

#acip #fda #legal-challenges

health-policy5 days ago•2 min saved

FDA chief vows tighter safety review of antidepressants in pregnancy and RSV protections for infants

In her first staff address, FDA’s top drug regulator Tracy Beth Høeg pledges tougher safety monitoring of antidepressants used in pregnancy and RSV monoclonal antibodies for infants, signaling a broader push to reexamine oversight and encouraging staff to question norms.

via statnews.com|

#antidepressants #fda #health-policy

health6 days ago•14 min saved

Moderna's mRNA flu shot moves to FDA review after dispute resolution

Moderna says the FDA will review its experimental mRNA-based flu vaccine after resolving a public dispute, signaling movement toward potential regulatory consideration of the shot.

via AP News|

#fda #flu-vaccine #health

policy7 days ago•7 min saved

FDA Misses Cannabinoid Lists Deadline as Hemp Rules Brace for Major Change

FDA failed to publish congressionally mandated lists of cannabinoids and to define what qualifies as a “container” for hemp products by the deadline, even as a November switch to a stricter hemp regime looms. The new rules would base legality on total THC (including delta-8) and other closely related cannabinoids, impose a per-container cap, and ban intermediates or non-naturally produced cannabinoids. Industry groups are pressing Congress to delay the ban and extend regulatory work, while alternatives like the HEMP Act seek to shape the forthcoming framework and testing/packaging requirements.

via Marijuana Moment|

#cannabinoids #container #fda

business7 days ago•4 min saved

Reese's founder's grandson accuses Hershey of diluting the iconic recipe

Brad Reese, the inventor's grandson, accuses Hershey of replacing milk chocolate with compound coatings and peanut butter with creme across Reese's products, threatening brand trust. Hershey says the changes are recipe adjustments to support innovations while preserving the core chocolate-and-peanut-butter balance. The dispute references new heart-shaped Minis, European variants, FDA labeling rules, and price pressures that influence formulations.

via CBS News|

#brad-reese #business #fda