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FDA’s Gottlieb tells state ag bosses how FSMA is going to work

The U.S. Food and Drug Administration Commissioner Scott Gottlieb Tuesday talked about compliance with new food regulations at the Annual Meeting of the influential National Association of State Departments of Agriculture (NASDA) in New Orleans. Show More Summary

U.S. FDA approves GSK's three-in-one drug inhaler for COPD

(Reuters) - GlaxoSmithKline Plc and Innoviva Inc said on Monday the U.S. Food and Drug Administration has approved their triple drug inhaler for treatment of chronic obstructive pulmonary disease (COPD).

Reading list: consequences of 1A protections for off-label promotion

2 days agoIndustries / Law : 43(B)log

Patricia J. Zettler, The Indirect Consequences of Expanded Off-Label Promotion, Ohio State Law Journal, Forthcoming The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. Show More Summary

FDA warns cattle feed, cheese, supplement producers

A Kentucky cattle feed manufacturer, a Vermont cheese processing facility, and a New York supplement facility are all on notice from the Food and Drug Administration for violations of federal food safety rules. The FDA sent the warning letters to the companies in August and September, and posted them for public view in recent days. Companies are allowed... Continue Reading

Exclusive: FDA plans new compounding pharmacy policy, agency head says

BOSTON (Reuters) - The head of the U.S. Food and Drug Administration said on Friday the agency is working on a new policy that would encourage more compounding pharmacies to register under a law enacted in the wake of a deadly 2012 meningitis outbreak linked to one such company.

U.S. FDA approves Bayer drug to treat follicular lymphoma

(Reuters) - The U.S. Food and Drug Administration said on Thursday it has approved Bayer AG's treatment for follicular lymphoma, a cancer of the lymph system.

U.S. FDA approves biosimilar version of cancer drug Avastin

(Reuters) - The U.S. Food and Drug Administration said on Thursday it has approved Amgen Inc's biosimilar version of Roche Holding AG's cancer drug Avastin.

'Impressed' FDA panel unanimously recommends GSK shingles vaccine

(Reuters) - A U.S. Food and Drug Administration advisory panel on Wednesday voted 11-0 that the safety and efficacy of GlaxoSmithKline's Shingrix shingles vaccine warrants approval for its use in adults aged 50 and over.

FDA Moves To Guard Against Abuse Of ‘Orphan Drug’ Program

last weekHealth : The Checkup

The Food and Drug Administration is changing the way it approves medicines known as “orphan drugs” after revelations that drugmakers may be abusing a law intended to help patients with rare diseases....

FDA Breaks New Ground With First Approved Gene Therapy for Cancer

When oncologist Dr. Carl June heard the Food and Drug Administration’s decision to bring the first gene therapy to market in the US, he pinched himself, hard. “It was so improbable that this would ever be a commercially approved therapy,” he said, voice breaking with emotion. June was referring to a revolutionary cancer therapy that […]

FDA warns beef, fruit juice and seafood processors to clean up

A Texas beef cattle operation, a Puerto Rican fruit juice processor, and three seafood processors in New Jersey, New York and Poland are all on notice from the Food and Drug Administration for violations of federal food safety rules....Show More Summary

Novartis says biosimilar rituximab accepted for review by FDA

ZURICH (Reuters) - Novartis AG said on Tuesday its biosimilar rituximab to treat blood cancers and immunological diseases such as rheumatoid arthritis was accepted for review by the U.S. Food and Drug Administration (FDA).

FDA Gives Okay For PTSD Sufferers To Start Ecstasy Trials

There is great news for the nearly 5.2 million people in the United States that suffer from Post-Traumatic Stress Disorder (PTSD). The F00d and Drug Administration (FDA) has given their approval for 3-4 methylenedioxymethamphetamine (MDMA), better known as the street drug ecstasy, to be used in Phase 3 trials for the treatment of PTSD. Show More Summary

New FDA Guide Should Help Small Farmers Comply with Food Safety Regs

The U.S. Food and Drug Administration has published a guide for farmers to keep in line with regulations imposed by the Food Safety Modernization Act.

FDA faces suit for failing to reveal retailers in papaya outbreak

The Center for Science in the Public Interest (CSPI) wants the Food and Drug Administration to release the names and locations of supermarkets and other retailers who sold papayas now subject to a nationwide recall because of a Salmonella outbreak. But FDA won’t do it, even though another federal food safety agency routinely makes such... Continue Reading

FDA puts Celgene's multiple cancer trials on hold

(Reuters) - Celgene Corp said on Thursday the U.S. Food and Drug Administration had placed a partial clinical hold on the company's five trials and a full clinical hold on one trial.

Bristol-Myers says FDA places partial hold on Opdivo myeloma trials

(Reuters) - The U.S. Food and Drug Administration has placed a partial hold on three clinical trials testing Bristol-Myers Squibb's immunotherapy Opdivo in combination with other medicines for multiple myeloma due to risks seen in similar studies involving a rival drug, the company said on Wednesday.

FDA Approves First Gene Therapy For Leukemia

The Food and Drug Administration on Wednesday announced what the agency calls a "historic action" -- the first approval of a cell-based gene therapy in the United States. The FDA approved Kymriah, which scientists refer to as a "living drug" because it involves using genetically modified immune cells from patients to attack their cancer. Show More Summary

FDA issues warning letters to handlers of sprouts, fish products

A California sprout processor, a Denver fish processor and a New York seafood importer are all on notice from the Food and Drug Administration for violations of the federal Food, Drug & Cosmetic Act. Two of the three facilities confirmed...Show More Summary

Three reasons why pacemakers are vulnerable to hacking

The US Food and Drug Administration (FDA) recently recalled approximately 465,000 pacemakers made by the company Abbott's (formerly St. Jude Medical) that were vulnerable to hacking, but the situation points to an ongoing security problem.

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