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Blood-Brain Barrier Disruptor Device Gets Breakthrough

[ Price : $8.95]

FDA grants Carthera a breakthrough device designation for its SonoCloud-9 system, a device that uses low intensity pulsed ultrasou...

Info Collection on Human Subject Protection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Protection of Human Subjects; Informed...

Guide on Rescinding Breakthrough Therapy Designations

[ Price : $5.00]

Federal Register notice: FDA makes available a draft guidance entitled Considerations for Rescinding Breakthrough Therapy Designat...

Drug GMP Guide on Preventing Cross-Contamination

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Prev...

Guide on Food Effect Clin-Pharm Considerations

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Assessing the Effects of Food on Drugs in INDs and NDAs Cl...

Guide on Oligonucleotide Therapeutic Development

[ Price : $8.95]

FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeu...

Non-Penicillin Beta-Lactam Drug Guidance

[ Price : $8.95]

FDA publishes a draft revising a 2013 guidance on a CGMP framework for preventing cross-contamination in non-penicillin beta-lacta...

Baxter Volara System Recall is Class 1

[ Price : $8.95]

FDA says the Baxter Healthcare recall of its Volara system due to risk of respiratory distress in home use is Class 1.

Info Collection on 510(k) 3rd-Party Review Program

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled 510(k) Third-Party Review Program (OMB...

Info Collection on Device Registration/Listing

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Establishment Registration and Device Listi...