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TXT Guide on Genetic Variant Databases for IVD Support [140 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics; Guidance for Stakeholders and Food and Drug Administration Staff.”
04/16/2018
 
 
TXT FDA Backpedals on Alkermes NDA Filing Rufusal [261 Words] [ Price : $8.95]
FDA rescinds an Alkermes refuse-to-file letter issued late last month on its NDA for ALKS 5461 (buprenorphine and samidorphan), an investigational drug for the adjunctive treatment of major depressive disorder.
04/16/2018
 
 
TXT 12 Observations in Celltrion FDA-483 [2832 Words] [ Price : $8.95]
FDA releases the FDA-483 detailing 12 observations from a 2017 inspection at Korea’s Celltrion drug manufacturing facility.
04/13/2018
 
 
TXT Final Guidance on Special Protocol Assessments [240 Words] [ Price : $8.95]
FDA posts a guidance on Special Protocol Assessment that provides drug manufacturers with information about the procedures and policies adopted by CDER/CBER for reaching an agreement on the design and size of certain clinical trials that could support marketing approval.
04/13/2018
 
 
TXT Panel to Review Siga Tech Smallpox NDA [89 Words] [ Price : $8.95]
Federal Register notice: FDA announces a 5/1 Antimicrobial Drugs Advisory Committee meeting to discuss a Siga Technologies NDA for tecovirimat.
04/13/2018
 
 
TXT Info Collection Extension on Dispute Resolution [103 Words] [ Price : $8.95]
Federal Register notice: FDA submits for OMB approval an information collection extension for its “Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice.”
04/13/2018
 
 
TXT Guide on Ultrasonic Diathermy Device 510(k)s [148 Words] [ Price : $8.95]
FDA releases a final guidance on “Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices.”
04/13/2018
 
 
TXT NJ Court Hands Down $33 Million Verdict Against Bard [156 Words] [ Price : $8.95]
A state court jury in New Jersey hands down a $33 million verdict against C.R. Bard in a product liability lawsuit involving its allegedly defective pelvic mesh implants.
04/13/2018
 
 
TXT Info Collection Extension for Accredited Persons Inspections [93 Words] [ Price : $8.95]
Federal Register notice: FDA submits to OMB for approval an information collection extension for “Notification of the Intent To Use An Accredited Person Under the Accredited Persons Inspection Program.”
04/13/2018
 
 
TXT Alert on Recalled Coastal Meds Sterile Drugs [104 Words] [ Price : $8.95]
FDA alerts health care professionals about a recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in some drug vials for injection.
04/13/2018
 
 
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