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blogs.fda.gov

 •  January 10

By: Janet Woodcock, M.D. In 2017, FDA’s Center for Drug Evaluation and Research (CDER) approved many new drugs never before marketed in the United States, known as “novel” drugs, to help improve people’s health. Novel drugs often represent innovative therapies for advancing patient care. 2017 was no exception. We approved new treatments for...

blogs.fda.gov

 •  January 9

By: Scott Gottlieb, M.D. As we look ahead to 2018, I’d like to take a moment to reflect on an inspiring year of advances in both medicine and public health for FDA — from groundbreaking medical products brought to market this year, to a record number of generic drug approvals that will promote competition, and to the agency’s ongoing efforts to...

blogs.fda.gov

 •  December 14, 2017

By: Scott Gottlieb, M.D. Twice a year the federal government publishes the “Unified Agenda of Federal Regulatory and Deregulatory Actions” (Unified Agenda), which provides the American public with insight into regulations under development or review throughout the federal government. For the U.S. Food and Drug Administration (FDA), it gives us an...

blogs.fda.gov

 •  December 8, 2017

By: Peter Stein. M.D. Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be both effective and safe for use if prescribed according to its labeling. However, there may be issues that need additional evaluation after approval. For example, post-approval studies may be needed to confirm clinical...

blogs.fda.gov

 •  November 8, 2017

By: Theresa Toigo, MBA, RPh For some FDA-approved drugs specific safety steps must be taken before the patient can receive the medication. These measures, which may involve the patient, health care providers and manufacturers, are part of an FDA-required program called a risk evaluation and mitigation strategy (REMS). They are specifically designed...

blogs.fda.gov

 •  October 17, 2017

By: Kathleen Uhl, M.D., and Michael Kopcha, Ph.D., R.Ph. We marked an important milestone in the U.S. generic drug program on Oct. 1, 2017 – the start of the first reauthorization of the Generic Drug User Fee Amendments (GDUFA). These fees from industry provide FDA with vital funding that advances the Agency’s regulatory work to review and approve...

blogs.fda.gov

 •  October 2, 2017

By: Scott Gottlieb, M.D. Earlier this year, I announced our Drug Competition Action Plan to advance new policies aimed at bringing more competition to the drug market. My goal was to improve access consumers have to the medicines that they need. I consider access to medicine a matter of public health. If consumers are priced out of the drugs they...

blogs.fda.gov

 •  September 12, 2017

By: Scott Gottlieb, M.D. Three months ago, I committed to fully eliminate a backlog of about 200 orphan drug designation requests that were pending review with FDA, and to implement policies that would require FDA to respond to all new designation requests within 90 days of receiving them. Moreover, the agency pledged to never allow a backlog of...

blogs.fda.gov

 •  September 4, 2017

By: Pamela E. Scott, Ph.D. When women are pregnant they take care to eat right and refrain from smoking and drinking alcoholic beverages. But what to do about prescription drugs is a more complicated topic. There are very few prescription medications that have been specifically approved for use during pregnancy. And yet, doctors in clinical...

blogs.fda.gov

 •  August 9, 2017

By: Theresa M. Mullin, Ph.D. Increasingly, drug development is a global endeavor. It requires international collaboration to ensure that consistent standards are adopted and adhered to by all drug makers and regulatory authorities, regardless of country of origin or destination. FDA’s Theresa Mullin (center) and the FDA delegation engaging in a...