FDA

FDA Delays Contentious Medical Device Intended Use Rule
FDA Delays Contentious Medical Device Intended Use Rule
Emergo
FDA
devices
intended use
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Industry awaits FDA on rules for real-world evidence
Industry awaits FDA on rules for real-world evidence
Biopharma Dive
FDA
RWE
real world evidence
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FDA approves Novartis-acquired Lutathera for certain gut cancers
FDA approves Novartis-acquired Lutathera for certain gut cancers
Biopharma Dive
Novartis
FDA
Lutathera
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Roche scores an unusual ‘breakthrough’ at the FDA for an autism drug
Roche scores an unusual ‘breakthrough’ at the FDA for an autism drug
Endpoints
Roche
FDA
breakthrough status
autism
RG7314
balovaptan
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Novartis scores a quick FDA OK for its new cancer drug Lutathera, picked up in $4B buyout
Novartis scores a quick FDA OK for its new cancer drug Lutathera, picked up in $4B buyout
Endpoints
Novartis
Lutathera
FDA
neuroendocrine tumors
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Evolus says its Botox biosimilar could be delayed by FDA issues with Daewoong plant
Evolus says its Botox biosimilar could be delayed by FDA issues with Daewoong plant
Fierce Pharma
Evolus
Botox
biosimilars
FDA
drug manufacturing
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Gottlieb: Shutdown means furloughs for 42% of FDA staff
Gottlieb: Shutdown means furloughs for 42% of FDA staff
Mass Device
FDA
federal government
government shutdown
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FDA to Expedite Release of Recall Information
FDA to Expedite Release of Recall Information
FDA Voice
FDA
recalls
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FDA releases top 3 medical device regulation goals
FDA releases top 3 medical device regulation goals
Fierce Pharma
FDA
devices
regulation
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FDA and Pentagon Forge Breakthrough Designation Agreement
FDA and Pentagon Forge Breakthrough Designation Agreement
RAPS.org
FDA
Pentagon
Department of Defense
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New Jersey Finalizes New Limits on Pharmaceutical Manufacturer Gifts and Payments to Prescribers
New Jersey Finalizes New Limits on Pharmaceutical Manufacturer Gifts and Payments to Prescribers
FDA Law Blog
New Jersey
physician payments
FDA
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Diabetes data company urges FDA to make pre-cert program scalable
Diabetes data company urges FDA to make pre-cert program scalable
Drug Delivery Business News
diabetes
FDA
data
Tidepool
pre-certification
digital health
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FDA Looks Ahead and Back on Orally Inhaled and Nasal Generic Drugs
FDA Looks Ahead and Back on Orally Inhaled and Nasal Generic Drugs
RAPS.org
FDA
inhaled drugs
generics
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Can a hip replacement kill you: lack of regulation in the med device industry
Can a hip replacement kill you: lack of regulation in the med device industry
NY Times, NY
FDA
devices
regulation
hip implants
JNJ
Medtronic
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Glaxo's Influenza Vaccine Gets FDA Nod for Label Expansion
Glaxo's Influenza Vaccine Gets FDA Nod for Label Expansion
Yahoo/Zacks.com
GSK
flu vaccines
FDA
FluarixQuadrivalent
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Aradigm crashes after FDA panel votes down antibiotic
Aradigm crashes after FDA panel votes down antibiotic
Fierce Biotech
Aradigm
FDA
advisory panels
antibiotics
Linhaliq
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FDA Delays Implementing Parts of 'Intended Use' Rule
FDA Delays Implementing Parts of 'Intended Use' Rule
RAPS.org
FDA
intended use
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FDA revises label on opioid cold meds to limit pediatric use
FDA revises label on opioid cold meds to limit pediatric use
Drug Delivery Business News
FDA
opioids
pediatrics
labeling
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In a pioneering first, AstraZeneca scores FDA OK to use its PARP against breast cancer
In a pioneering first, AstraZeneca scores FDA OK to use its PARP against breast cancer
Endpoints
AstraZeneca
PARP inhibitors
FDA
Lynparza
metastatic breast cancer
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The FDA still hates low T drugs — experts bat back a pair of contenders
The FDA still hates low T drugs — experts bat back a pair of contenders
Endpoints
FDA
testosterone
Lipocine
Tlando
Clarus Therapeutics
Jatenzo
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