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FDA approves Striverdi Respimat to treat chronic obstructive pulmonary disease

Today, the U.S. Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that... read more

FDA takes steps to help ensure the reliability of certain diagnostic tests

Today, the U.S. Food and Drug Administration took important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent... read more

FDA Commissioner Margaret A. Hamburg?s Statement on the Surgeon General?s Call to Action to Prevent Skin Cancer

Each year, thousands of Americans are diagnosed with some form of skin cancer. The Surgeon General?s Call to Action to prevent skin cancer is important especially during these hot... read more

FDA expands approved use of Imbruvica for chronic lymphocytic leukemia

The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p... read more

Food and Drug Adminstration (FDA): CDRHNew

Companion Diagnostics

A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological... read more

FDA Voice Blog: Curbing Risk, Not Medical Innovation, in Personalized Medicine

Innovative new tests are routinely submitted to the Food and Drug Administration to assure they are safe and effective. They include genetic tests that help oncologists decide whether a patient... read more

In Vitro Companion Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff

This guidance is intended to assist (1) sponsors who are planning to develop a therapeutic product1 (either a novel product or an existing product with a new indication) for which the... read more

Laboratory Developed Tests

A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. LDTs can be used to measure or... read more

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Summary Basis for Regulatory Action - ALPROLIX

August 30, 2010 Clarification Letter - Afluria

clarify your pediatric study fulfillment requirements that were omitted from our approval letter, dated November 10, 2009

Providing Submissions in Electronic Format ? Postmarketing Safety Reports for Vaccines

Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products

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