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Human Drugs

FDA Redesigns Drug Shortage Web Page

FDA redesigns its drug shortage Web page to make it easier to quickly locate current shortage information.

Human Drugs

Depressive Disorder Drug Development Guidance

FDA releases a draft guidance to help sponsors with clinical development of drugs to treat major depressive disorder.

Inhaler Quality Consideration Issues Raised

Four stakeholders raise concerns with an FDA docket and draft guidance on quality considerations for metered dose and dry powder inhalers.

Human Drugs

Right-to-Try Could Upset Access/Safety Balance: Study

Yale University researchers caution that right-to-try laws can upset the balance between access and safety FDA has reached with drug manufacturers in ...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Biologique Recherche and Oeyama-Moto Medical Group Foundation.

Human Drugs

New Generic Drug Development Initiatives

FDA commissioner Scott Gottlieb describes two new initiatives he wants to have funding in the agencys next budget to further promote generic drug deve...

Human Drugs

CGMP Violations at Frances Biologique Recherche

FDA warns Frances Biologique Recheche about CGMP violations in its production of finished drugs.

Medical Devices

FDA Approves 2 Grifols Blood Screening Assays

FDA approves two Grifols blood screening assays: Procleix Ultrio Elite and Procleix WNV.

Medical Devices

FDA Wants Precertification Pilot Input

FDA solicits stakeholder input on the latest version of its software precertification program working model.

Medical Devices

FDA Updates Alert on Endovascular Graft Systems

FDA says it continues to evaluate information from several sources, including endovascular graft system manufacturers, about the risks associated with...