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Lilly Plans 2019 NDA for Diabetes Therapy URLi

[ Price : $8.95]

Eli Lilly plans to submit an NDA for Ultra Rapid Lispro in 2019 after reporting favorable clinical trial data from two Phase 3 tri...

Special 510(k) Program Draft Guidance

[ Price : $8.95]

Federal Register notice: FDA issues a draft guidance entitled The Special 510(k) Program.

FDA Debars Richard Fleming Due to Fraud Probe

[ Price : $8.95]

Federal Register notice: FDA issues an order to debar Richard M. Fleming for 10 years from providing services in any capacity to a...

PET Drug CGMP Violations at N-Molecular

[ Price : $8.95]

FDA warns N-Molecular about CGMP violations in its production of PET drugs.

Guide on Atopic Dermatitis Pediatric Studies

[ Price : $8.95]

FDA posts a guidance entitled Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.

Package Type Guidance

[ Price : $8.95]

FDA issues a guidance with recommendations for selection of appropriate package type terms and appropriate discard statements for ...

Optimize Emergency Trial Pathway for Public Trust: Study

[ Price : $8.95]

Researchers suggest a change in FDA reporting requirements for exception from informed consent clinical trials to better describe ...

Amerisource Bergen Settles Cancer Drug Charges for $625 Million

[ Price : $8.95]

The Justice Department says Amerisource Bergen is paying $625 million to resolve three whistleblower suits claiming that it operat...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Datascope Corp. and Sofie Biosciences.

Acessa Health Fibroid Device Cleared

[ Price : $8.95]

FDA clears an Acessa Health 510(k) for the Acessa ProVu System, an integrated radiofrequency ablation, ultrasound visualization, a...