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TXT Drug and Bio Development Times Similar: Analysis [5261 Words] [ Price : $8.95]
Researchers say there is no significant difference in drug development time between small molecule drugs and biologics.
06/18/2019
 
 
TXT CGMP Violations at Tropical Seas [2812 Words] [ Price : $8.95]
FDA warns Tropical Seas about CGMP and other violations in its manufacturing of several over-the-counter drugs.
06/18/2019
 
 
TXT Info Collection Extension for Social/Behavioral Research [121 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for “Data to Support Social and Behavioral Research as Used by the Food and Drug Administration.”
06/18/2019
 
 
TXT Info Collection Extension on Device Postmarket Surveillance [116 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled “FDA Postmarket Surveillance of Medical Devices — 21 CFR Part 822” (OMB Control Number 0910-0449).
06/18/2019
 
 
TXT Cook Recalls Advance Enforcer Balloon Catheter [118 Words] [ Price : $8.95]
Cook Medical recalls its Advance Enforcer 35 Focal-Force PTA Balloon Catheter (6mm x 4cm) after multiple complaints were received for balloons bursting below the rated burst pressure.
06/18/2019
 
 
TXT Latest FDA Warning Letters [264 Words] [ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes PRL, Inc. and Tropical Seas.
06/18/2019
 
 
TXT FDAers Develop Better Poliovirus Assay [2783 Words] [ Price : $8.95]
FDA scientists say they have developed a new and improved poliovirus assay.
06/18/2019
 
 
TXT Multiple Dietary Supplement Violations at PRL [3047 Words] [ Price : $8.95]
FDA warns PRL, Inc., about CGMP and other violations in its production of dietary supplements.
06/18/2019
 
 
TXT FDA Enhances Paragraph 4 Patent List [2725 Words] [ Price : $8.95]
FDA acting commissioner Ned Sharpless says the agency is enhancing the data in the generic drug Paragraph 4 patent certification list as part of an effort to bolster generic drug competitiveness.
06/18/2019
 
 
TXT Abeona Therapeutics Gains Fast Track for Gene Therapy [193 Words] [ Price : $8.95]
FDA grants Abeona Therapeutics a fast track designation for ABO-202, a novel one-time AAV9 gene therapy for CLN1 disease.
06/18/2019
 
 
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