FDA

FDA Withdraws Proposed Rule on Generic Label Changes
FDA Withdraws Proposed Rule on Generic Label Changes
RAPS.org
FDA
labeling
generics
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FDA hails 2018 as bumper year for drug development successes
FDA hails 2018 as bumper year for drug development successes
Fierce Biotech
FDA
drug development
drug approvals
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Government shutdown could hobble FDA
Government shutdown could hobble FDA
BioCentury
FDA
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Lawsuit Charges FDA, NIH With Failing to Follow Established Law for Reporting of Clinical Trial Data
Lawsuit Charges FDA, NIH With Failing to Follow Established Law for Reporting of Clinical Trial Data
BioSpace
FDA
clinical trials
NIH
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Mallinckrodt's woes persist as reformulated opioid painkiller fails to pass FDA muster
Mallinckrodt's woes persist as reformulated opioid painkiller fails to pass FDA muster
Endpoints
Mallinckrodt
FDA
opioids
abuse-resistant painkillers
Roxicodone
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FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics
FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics
RAPS.org
FDA
biosimilars
biologics
BPCIA
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Gottlieb blasts high insulin prices, touts far-off new rules he says will spur competition in that market
Gottlieb blasts high insulin prices, touts far-off new rules he says will spur competition in that market
Stat
FDA
Scott Gottlieb
insulin
diabetes
drug pricing
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FDA advisory panel to mull transvaginal mesh
FDA advisory panel to mull transvaginal mesh
Mass Device
FDA
devices
transvaginal mesh
advisory panels
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FDA grants breakthrough status to joint Merck-Bayer AI program
FDA grants breakthrough status to joint Merck-Bayer AI program
Mass Device
Merck
Bayer
FDA
breakthrough status
devices
CTEPH
artificial intelligence
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FDA slaps partial hold on MacroGenics for bispecific cancer trials as liver tox spurs safety fears
FDA slaps partial hold on MacroGenics for bispecific cancer trials as liver tox spurs safety fears
Endpoints
Macrogenics
FDA
bispecific antibodies
clinical trials
B7-H3 × CD3
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FDA Drafts Guidance on Oncology Companion Diagnostics
FDA Drafts Guidance on Oncology Companion Diagnostics
RAPS.org
FDA
cancer companion diagnostics
oncology
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Renal Denervation: FDA Panel, Industry Mostly on the Same Page
Renal Denervation: FDA Panel, Industry Mostly on the Same Page
MedPage
devices
renal denervation
FDA
hypertension
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FDA Flags Pfizer’s Hospira Plant in Kansas Over Repeat 483 Citations
FDA Flags Pfizer’s Hospira Plant in Kansas Over Repeat 483 Citations
RAPS.org
FDA
Pfizer
drug manufacturing
Hospira
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Bipartisan bill would revamp diagnostics regulation
Bipartisan bill would revamp diagnostics regulation
BioCentury
congress
FDA
diagnostics
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Genentech Scores FDA Approval for Tecentriq and Avastin Combo in NSCLC
Genentech Scores FDA Approval for Tecentriq and Avastin Combo in NSCLC
BioSpace
Genentech
FDA
Tecentriq
Avastin
non-squamous cell non-small cell lung cancer
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Nearly 300 gene and cell therapies in development – report
Nearly 300 gene and cell therapies in development – report
Pharmaforum
gene therapy
cell therapy
FDA
PhRMA
drug development
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FDA Will Allow Observational Studies to Support Effectiveness Determinations, New Framework Says
FDA Will Allow Observational Studies to Support Effectiveness Determinations, New Framework Says
RAPS.org
FDA
real world evidence
real world data
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FDA breaks NME approval record in 2018
FDA breaks NME approval record in 2018
BioCentury
FDA
drug approvals
NMEs
new molecular entity
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Tecentriq could be first front-line SCLC therapy approved in two decades
Tecentriq could be first front-line SCLC therapy approved in two decades
BioCentury
FDA
Tecentriq
Genentech
extensive-stage small cell lung cancer
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Pops Diabetes wins FDA clearance for blood glucose monitoring system
Pops Diabetes wins FDA clearance for blood glucose monitoring system
Mass Device
Pops Diabetes Care
FDA
blood glucose monitoring
mobile apps
devices
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