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FDA’s New Pilot Program Aims for More Transparency about New Drug Approvals

FDA’s New Pilot Program Aims for More Transparency about New Drug Approvals

FDA Voice

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FDA Explains Physician Survey on Drug Marketing

FDA Explains Physician Survey on Drug Marketing

RAPS.org

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Genetic tests ordered by doctors race to market, while ‘direct-to-consumer’ tests hinge on FDA approval

Genetic tests ordered by doctors race to market, while ‘direct-to-consumer’ tests hinge on FDA approval

Stat

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Amazon is hiring a former FDA official to work on its secretive health tech business

Amazon is hiring a former FDA official to work on its secretive health tech business

CNBC

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New FDA Generic Drug Reports Tabulate Approval Times

New FDA Generic Drug Reports Tabulate Approval Times

RAPS.org

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FDA's promo police put pharma marketing to the test with 6 new research studies

FDA's promo police put pharma marketing to the test with 6 new research studies

Fierce Pharma

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Abeona Therapeutics Receives FDA Rare Pediatric Disease Designation for ABO-202 Gene Therapy Program in CLN1 Disease

Abeona Therapeutics Receives FDA Rare Pediatric Disease Designation for ABO-202 Gene Therapy Program in CLN1 Disease

CP Wire

Abeona Therapeutics

Rare Pediatric Disease designation

priority review vouchers

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Abeona Therapeutics Receives FDA Rare Pediatric Disease Designation for ABO-202 Gene Therapy Program in CLN1 Disease

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Solid Bio's DMD gene therapy graduates from partial FDA hold to full-on clinical hold

Solid Bio's DMD gene therapy graduates from partial FDA hold to full-on clinical hold

Fierce Biotech

Solid Biosciences

Duchenne Muscular Dystrophy

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After a rough season, FDA chief Gottlieb says 'holy grail' flu shot is years off

After a rough season, FDA chief Gottlieb says 'holy grail' flu shot is years off

Fierce Pharma

universal flu vaccine

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Patient death forces FDA to slap a hold on study using combo from Advaxis, AstraZeneca — biotech’s shares plunge

Patient death forces FDA to slap a hold on study using combo from Advaxis, AstraZeneca — biotech’s shares plunge

Endpoints

clinical trials

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FDA Lays Out Plans for Future Research on Pharmaceutical Ads and Promotions

FDA Lays Out Plans for Future Research on Pharmaceutical Ads and Promotions

RAPS.org

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Healthcare on the Hill - House to vote on revised "Right to Try" Act

Healthcare on the Hill - House to vote on revised "Right to Try" Act

CP Wire

Healthcare on the Hill

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Healthcare on the Hill - House to vote on revised "Right to Try" Act

Healthcare on the Hill

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Sarepta to seek FDA approval for its second Duchenne’s drug by year’s end

Sarepta to seek FDA approval for its second Duchenne’s drug by year’s end

Stat

Sarepta Therapeutics

Duchenne Muscular Dystrophy

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FDA Cracks Down on Duodenoscope Manufacturers Again

FDA Cracks Down on Duodenoscope Manufacturers Again

Medical Devices and Diagnostics Industry

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ACC: Waiting on the FDA's heart-helping verdict, J&J touts more positive CV data for Invokana

ACC: Waiting on the FDA's heart-helping verdict, J&J touts more positive CV data for Invokana

Fierce Pharma

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Did FDA Miss the Mark on the Essure Controversy?

Did FDA Miss the Mark on the Essure Controversy?

Medical Devices and Diagnostics Industry

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Pfizer Gets FDA Panel Backing for New Indication for Xeljanz

Pfizer Gets FDA Panel Backing for New Indication for Xeljanz

Yahoo/Zacks.com

advisory panels

ulcerative colitis

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Five Events That Disrupted the Diabetes Market

Five Events That Disrupted the Diabetes Market

Medical Devices and Diagnostics Industry

blood glucose monitoring

artificial pancreas

FreeStyle Libre Flash

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