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Questions and Answers on Draft Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in REMS. September 28, 2016 - FDA approves first automated insulin delivery device for type 1 diabetes. Some links in press announcements may no longer be active. Get email alerts when the Medication Guides page is updated. November 17, 2016 - FDA approves Intrarosa for postmenopausal women experiencing pain during sex. December 07, 2016 - FDA takes steps to improve hearing aid accessibility. December 09, 2016 - FDA takes action against four tobacco manufacturers for illegal sales of flavored cigarettes labeled as little cigars or cigars. December 14, 2016 - FDA approves Eucrisa for eczema. December 14, 2016 - FDA Statement from Dr. September 30, 2016 - FDA warns against the use of homeopathic teething tablets and gels. December 13, 2016 - FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee. December 19, 2016 - FDA grants accelerated approval to new treatment for advanced ovarian cancer. Postmarket Drug Safety Information for Patients and Providers. October 19, 2016 - FDA grants accelerated approval to new treatment for advanced soft tissue sarcoma.
November 17, 2016 - FDA research to help speed development of Zika virus vaccines and therapeutics. December 02, 2016 - FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. September 23, 2016 - FDA approves expanded indications for Ilaris for three rare diseases. October 17, 2016 - FDA awards 21 grants to stimulate product development for rare diseases. This website has been translated to Spanish from English, and is updated often. Public Hearing on Use of Medication Guides to Distribute Drug Risk Information to Patients June 12-13, 2007. September 23, 2016 - FDA approves Amjevita, a biosimilar to Humira. Medication Guides are paper handouts that come with many prescription medicines. December 14, 2016 - FDA takes action on applications seeking to market modified risk tobacco products. October 28, 2016 - FDA approves new device for prevention of recurrent strokes in certain patients. Note: Press announcements from 2004 to 2012 are available through the FDA Archive. November 30, 2016 - Food regulators seize adulterated milk products for food safety violations.
