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ACL Implant Gains De Novo Authorization

[ Price : $8.95]

FDA grants a de novo marketing authorization for Miach Orthopedics anterior cruciate ligament (ACL) implant for ACL reconstruction...

Abbott Virtual At-Home Covid Test Gets EUA

[ Price : $8.95]

FDA issues Abbott an Emergency Use Authorization for its virtually guided at-home use BinaxNOW Covid-19 Ag Card rapid test for det...

Develop Clinical Trial Data Strategy: Consultants

[ Price : $8.95]

YourEncore consultants describe in a white paper the value of having a clinical trial data strategy.

Grassley, Wyden Track Company Payments to Pain Groups

[ Price : $8.95]

Sens. Grassley and Wyden call for greater transparency in regulated industry payments to tax-exempt advocacy groups.

15 Observations in Advanced Nutriceuticals FDA-483

[ Price : $8.95]

FDA releases the FDA-483 detailing 15 inspection observations from an inspection at Advanced Nutriceuticals, a sterile drug produc...

EMD Serono Comments on Cybersecurity Communications

[ Price : $8.95]

EMD Serono suggests ways to improve an FDA discussion paper on communicating cybersecurity vulnerabilities to patients.

Feds Discuss Pfizer Vaccine Manufacturing Issues

[ Price : $8.95]

Federal officials report to the media that Pfizer is experiencing some vaccine manufacturing issues.

Gilead Abandons Jyseleca for RA in the U.S.

[ Price : $8.95]

Gilead Sciences and Galapagos abandon the U.S. development of Jyseleca (filgotinib) for Rheumatoid Arthritis after a recent meetin...

Desert Alchemist Selling Misbranded Unapproved New Drugs: FDA

[ Price : $8.95]

FDA warns Desert Alchemist it is selling misbranded and unapproved new drugs through its Etsy Web site.

EUA Granted for Fully At-Home Covid Test

[ Price : $8.95]

FDA issues an emergency use authorization for Ellumes Covid-19 Home Test, the first over-the-counter fully at-home diagnostic test...