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Follow FDA Online Misinformation Guidance: Attorneys

[ Price : $8.95]

Two Cooley attorneys urge companies regulated by FDA to follow the guidelines in a 7/8 draft guidance on responding to misinformat...

DeepWell Digital Software Cleared for Stress Relief

[ Price : $8.95]

FDA clears a DeepWell Digital Therapeutics 510(k) for its biofeedback software development kit for use in over-the-counter treatme...

Whole Exome Sequencing Devices are Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies whole exome sequencing devices into Class 2 (special controls).

Aisa Pharma Orphan Status for Cilnidipine

[ Price : $8.95]

Aisa Pharma wins an FDA orphan drug designation for its investigational drug AISA-021 (cilnidipine) and its use in treating system...

Cell-Free Nucleic Acid Collector is Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies blood collection devices for cell-free nucleic acids into Class 2.

GSK Highlights Depemokimab Asthma Data

[ Price : $8.95]

GSK says data from two clinical trials showed that depemokimab significantly reduces asthma exacerbations in patients with severe ...

Hold Removed on Rezolute Hypoglycemia Drug

[ Price : $8.95]

FDA removes a partial clinical hold against Rezolutes RZ358 (ersodetug), an investigational drug for treating hypoglycemia caused ...

Femasys Fallopian Tube Diagnostic Cleared

[ Price : $8.95]

FDA clears a Femasys 510(k) for its diagnostic device for checking the fallopian tubes to confirm permanent birth control placemen...

Lab Group Seeks Congress Help on LDT Rule

[ Price : $8.95]

The Association for Diagnostics and Laboratory Medicine raises significant concerns regarding the recent FDA final rule on laborat...

Class 2 for Endoscopic Pancreatic Debridement Devices

[ Price : $8.95]

Federal Register notice: FDA classifies endoscopic pancreatic debridement devices into Class 2 (special controls).