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TXT CDRH Listing on Upcoming Guidance Documents [118 Words] [ Price : $8.95]
Federal Register notice: FDA announces its Web site address where CDRH will post two lists of guidance documents that the Center intends to publish in fiscal year 2020.
10/11/2019
 
 
TXT Info Collection on 510(k) 3rd-party Reviews [82 Words] [ Price : $8.95]
Federal Register notice: FDA submits to OMB an information collection extension for “510(k) Third-Party Review Program.”
10/11/2019
 
 
TXT Innoveix Pharma Recalls Drugs Over Sterility Concerns [79 Words] [ Price : $8.95]
Innoveix Pharmaceuticals recalls all sterile compounded drug products due to sterility assurance concerns.
10/11/2019
 
 
TXT Info Collection Extension for CVM eSubmissions [85 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension for a guidance on cvm’s electronic submission system.
10/11/2019
 
 
TXT FDA Hits Cipla in India with 38-page Form-483 [129 Words] [ Price : $8.95]
FDA issues a highly redacted 38-page Form-483 following a recent inspection at drug manufacturer Cipla in Goa, India.
10/11/2019
 
 
TXT Lilly’s Reyvow Approved for Migraines [222 Words] [ Price : $8.95]
FDA approves Eli Lilly’s Reyvow (lasmiditan) tablets for the acute treatment of migraine with or without aura in adults.
10/11/2019
 
 
TXT FDA Clears Think Surgical Robotic Knee Replacement [97 Words] [ Price : $8.95]
FDA clears a Think Surgical 510(k) for the TSolution One Total Knee Application for use in total knee arthroplasty.
10/11/2019
 
 
TXT JAMA Article Raises Doubt on Replicating Trials [429 Words] [ Price : $8.95]
A new study in JAMA suggests there is limited feasibility for the idea of replicating clinical trials using real-world evidence.
10/11/2019
 
 
TXT FDA Clears Turn Therapeutics Wound Dressing [54 Words] [ Price : $8.95]
FDA clears a Turn Therapeutics 510(k) for the Protego Antimicrobial Wound Dressing.
10/11/2019
 
 
TXT 7 Observations on Aurobindo FDA-483 [2785 Words] [ Price : $8.95]
FDA releases an FDA-483 with seven observations from an inspection at an Aurobindo finished drug manufacturing facility.
10/10/2019
 
 
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