FDA to shut down secret recording program
When the FDA made the announcement, it said it would open past records within weeks. So why did the FDA have such a policy and why was it secret?
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TB ALLIANCE: FDA Advisory Committee Votes Favorably on the Question of the Effectiveness and Safety of Pretomanid in Combination with Bedaquiline and Linezolid for Treatment of Highly Drug-Resistant Forms of Tuberculosis
Investigational drug pretomanid, developed by non-profit TB Alliance, is under regulatory review for treatment of extensively drug-resistant tuberculosis and treatment-intolerant or non-responsive multidrug-resistant tuberculosis as part of a new investigational regimenthat includes bedaquiline and linezolid
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NULEAF NATURALS: CBD Provider NuLeaf Naturals Appears before FDA in Support of Industry Regulation and Standards
On May 31, NuLeaf Naturals representative Crystal Guess was one of 140 individuals to testify in a groundbreaking public meeting called by the Food and Drug Administration (FDA).
FDA OK'd 481 drugs in May
The U.S. Food and Drug Administration approved 481 drug products in May, according to an online list the agency updated this week.
Right to Try legislation sits in North Carolina senate committee
North Carolina House Bill 934, which passed unanimously 114-0, was sent to the State Senate where it currently is in committee.
DATA2LIFE: Data2Life's AI Powered RWE Platform Supports the CannaPharma Industry's Next Big Leap - Following FDA Concerns
Recent FDA hearing about CBD products emphasises the need for solid Real-Word Evidence Data
AIDOC: AI for C-Spine Fractures: Aidoc Sets the Pace With 3rd FDA Clearance in 9 Months
Aidoc's solution ensures patients with C-spine fractures are treated faster, saving lives
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U.S. FOOD AND DRUG ADMINISTRATION: Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys
At the U.S. Food and Drug Administration, increasing our scientific knowledge and capabilities is a cornerstone to ensuring the safety of the foods that Americans consume.
National Cannabis Industry Association urges FDA to regulate CBD
The National Cannabis Industry Association (NCIA) says the Federal Drug Administration (FDA) should take immediate steps to approve non-psychoactive cannabidiol components such as CBD for general use.
Hundreds of Thousands of Deaths a Year a 'Call to Action,' FDA Says on World Food Safety Day
The first World Food Safety Day was held on June 7 with deputy commissioner for food policy and response Frank Yiannas representing the Food and Drug Administration.
Project Facilitate will help physicians access unapproved therapies
A new pilot program, Project Facilitate, was announced last week by the Food and Drug Administration to help oncology health-care professionals access unapproved therapies for their cancer patients.
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CORMATRIX CARDIOVASCULAR, INC. receives FDA 510(k) clearance to market the Cor™ PATCH epicardial patch for tissue support and repair in adult patients
CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, announced FDA 510(k) clearance for the Cor™ PATCH. The Cor™ PATCH is indicated for epicardial tissue support and repair in adult patients.
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METVITAL, INC.: Announces FDA Clearance of Investigational New Drug (IND) Application for AEO for Phase 2 testing for Glioblastoma Multiforme
MetVital, Inc., a biopharmaceutical company developing small molecule modulators of glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential, announces that the U.S. Food and Drug Administration (FDA) has notified MetVital that it may proceed with its clinical investigation of "Anhydrous Enol-Oxaloacetate" (AEO) as a potential treatment for patients with Glioblastoma Multiforme.
Are price controls the answer when it comes to gene therapy drugs?
Some believe with the advent of gene therapy, the future of medicine has been seen.
Emerging biotech firms rival big pharma in new drug development, study finds
Emerging biotech companies developed nearly two-thirds of the new drug therapies approved last year in the United States, according to a new study by the pharmaceutical research company Iqvia.
EMCYTE CORPORATION: Announces FDA 510(k) Clearance for its PureBMC® Supraphysiologic Concentrating System
EmCyte, is proud to announce that it has received FDA 510(k) clearance for its PureBMC® Supraphysiologic Concentrating System.
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ARATANA THERAPEUTICS: Granted FDA Approval of NOCITA® (bupivacaine liposome injectable suspension) 10 mL Vial
Commercial availability of NOCITA 10 mL vial size anticipated by fall 2019
IBM, KPMG, Merck and Walmart to collaborate as part of FDA's program to evaluate the use of blockchain to protect pharmaceutical product integrity
The FDA pilot program explores innovative and emerging approaches for the tracing and verification of prescription products
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TRINETX: Applauds House Appropriations Committee for Supporting Use of Real-World Evidence in House Agriculture-FDA Spending Bill
TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE), praised the House Appropriations Committee for approving its fiscal year 2020 Agriculture, Rural Development, FDA, and Related Agencies bill which includes support for the use of RWE in regulatory decision making.
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HI-TECH PHARMACEUTICALS, INC.: The Government and FDA Ordered to Return Five Truckloads of DMAA to Hi-Tech Pharmaceuticals
Jared Wheat, CEO of Hi-Tech Pharmaceuticals, released the following statement in response to the return over $19 million worth of DMAA to Hi-Tech Pharmaceuticals