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Nektar’s pitch on early cancer drug OK runs into a regulatory brick wall

Nektar’s pitch on early cancer drug OK runs into a regulatory brick wall

Endpoints

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Report: New FDA guidance release rate falls post-Trump election

Report: New FDA guidance release rate falls post-Trump election

Mass Device

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Patient centricity? Pharma’s there, expert says. It’s regulators who need to catch up

Patient centricity? Pharma’s there, expert says. It’s regulators who need to catch up

Fierce Pharma

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8 Ways for Medtech to Navigate in Hazardous Conditions

8 Ways for Medtech to Navigate in Hazardous Conditions

Qmed

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Proposed Changes to the Device Intended Use Regulation

Proposed Changes to the Device Intended Use Regulation

FDA Law Blog

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New medical device rules from Indian regulators

New medical device rules from Indian regulators

Mass Device

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Sarepta, Patients Win - But What Of Regulatory Oversight?

Sarepta, Patients Win - But What Of Regulatory Oversight?

Seeking Alpha

Sarepta Therapeutics

Duchenne Muscular Dystrophy

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Regulatory Explainer: Everything You Need to Know About Biosimilars

Regulatory Explainer: Everything You Need to Know About Biosimilars

RAPS.org

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Medical device companies fear parallel regulation after Brexit vote

Medical device companies fear parallel regulation after Brexit vote

Mass Device

parallel regulation

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Brexit Won't Change Britain's Drug Regulatory Scheme

Brexit Won't Change Britain's Drug Regulatory Scheme

Forbes

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Sanofi R&D chief, ex-FDA head cite need to improve international regulatory coordination

Sanofi R&D chief, ex-FDA head cite need to improve international regulatory coordination

BioPharma Dive

Margaret Hamburg

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As U.S. biosim market grows, FDA's regulatory work has cost nearly $82 million

As U.S. biosim market grows, FDA's regulatory work has cost nearly $82 million

BioPharma Dive

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U.S., EU medical device associations push ‘regulatory cooperation’

U.S., EU medical device associations push ‘regulatory cooperation’

Mass Device

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Native advertising for pharma: Winning format or slippery slope to regulatory headaches?

Native advertising for pharma: Winning format or slippery slope to regulatory headaches?

Fierce Pharma Marketing

native advertising

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The Regulatory Quagmire Of Treatments For Sickle Cell Disease

The Regulatory Quagmire Of Treatments For Sickle Cell Disease

Forbes

sickle cell disease

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Sanofi R&D head bemoans divergence in global drug regulation

Sanofi R&D head bemoans divergence in global drug regulation

Yahoo/Reuters

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It's Not Just You: FDA Regulatory Requirements Really Are Increasing

It's Not Just You: FDA Regulatory Requirements Really Are Increasing

RAPS.org

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GI Dynamics hauls in $52.2M to get obesity tech through FDA

GI Dynamics hauls in $52.2M to get obesity tech through FDA

FierceMedicalDevice

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Taisho Pharma : New Agent for Osteoporosis Approved in Japan “Bonviva® IV Injection”

Taisho Pharma : New Agent for Osteoporosis Approved in Japan “Bonviva® IV Injection”

4 Traders

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FDA releases April 2013 PMA approvals

FDA releases April 2013 PMA approvals

Mass Device

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