regulatory

Report: New FDA guidance release rate falls post-Trump election
Report: New FDA guidance release rate falls post-Trump election
Mass Device
FDA
Donald Trump
regulatory
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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
patients
regulatory
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8 Ways for Medtech to Navigate in Hazardous Conditions
8 Ways for Medtech to Navigate in Hazardous Conditions
Qmed
devices
regulatory
AvaMed
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Proposed Changes to the Device Intended Use Regulation
Proposed Changes to the Device Intended Use Regulation
FDA Law Blog
devices
FDA
regulatory
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New medical device rules from Indian regulators
New medical device rules from Indian regulators
Mass Device
devices
India
regulatory
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Sarepta, Patients Win - But What Of Regulatory Oversight?
Sarepta, Patients Win - But What Of Regulatory Oversight?
Seeking Alpha
Sarepta Therapeutics
regulatory
Duchenne Muscular Dystrophy
FDA
eteplirsen
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Regulatory Explainer: Everything You Need to Know About Biosimilars
Regulatory Explainer: Everything You Need to Know About Biosimilars
RAPS.org
biosimilars
regulatory
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Medical device companies fear parallel regulation after Brexit vote
Medical device companies fear parallel regulation after Brexit vote
Mass Device
devices
regulatory
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
Brexit
UK
regulatory
EU
Europe
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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
Sanofi
R&D
FDA
Margaret Hamburg
regulatory
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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
biosimilars
FDA
regulatory
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U.S., EU medical device associations push ‘regulatory cooperation’
U.S., EU medical device associations push ‘regulatory cooperation’
Mass Device
Europe
United States
devices
regulatory
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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
drug ads
native advertising
regulatory
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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
regulatory
FDA
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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
Sanofi
R&D
regulatory
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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
FDA
regulatory
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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
GI Dynamics
FDA
obesity
regulatory
devices
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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
Tashio Pharma
osteoporosis
Japan
Bonviva
regulatory
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FDA releases April 2013 PMA approvals
FDA releases April 2013 PMA approvals
Mass Device
FDA
PMA
regulatory
devices
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AngioDynamics wins clearances in the U.S., Canada
AngioDynamics wins clearances in the U.S., Canada
Mass Device
AngioDynamics
US
Canada
FDA
regulatory
devices
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