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Antibacterial Therapy Q&A Guidance

[ Price : $8.95]

FDA publishes a draft guidance with questions and answers on developing antibacterial therapies for patients with an unmet medical...

Vanda Sues FDA to Overturn Fast Track Rejection

[ Price : $8.95]

Vanda Pharmaceuticals asks the DC federal court to set aside an FDA determination that the companys tradipitant does not qualify f...

RapidAI Pulmonary Embolism Identifier Cleared

[ Price : $8.95]

FDA clears a RapidAI 510(k) for its Rapid PE Triage & Notification product for identifying a suspected central pulmonary embolism.

INmune Bio Clinical Hold on TNF Therapy

[ Price : $8.95]

FDA places a clinical hold on an INmune Bio Phase 2 trial for XPro 1595, a next-generation inhibitor of tumor necrosis factor (TNF...

Aurobindo Pharma FDA-483

[ Price : $8.95]

FDA releases the FDA-483 with six observations from an inspection at Indias Aurobindo Pharma drug manufacturing facility.

Groups Suggest Changes to Device Quality System Reg

[ Price : $8.95]

Four medical device stakeholders voice general support for an FDA proposal to harmonize the medical device Quality System Regulati...

CDER Research Helping Generic Inhaler Development

[ Price : $8.95]

CDER researchers describe a study of mouth-throat models for generic metered-dose inhalers to help generic inhaler manufacturers m...

Teva Recalls 1 Lot of Anagrelide Capsules

[ Price : $8.95]

FDA says Teva recalled one lot of anagrelide capsules due to dissolution test failure.

Guide on Non-inferiority Trials for Antibacterials

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Antibacterial Therapies for Patients with an Unmet Medical ...

Guide on Drug Shortage Risk Management Plans

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Risk Management Plans to Mitigate the Potential for Drug Sh...