Innovation: News
We’re committed to encouraging advances when it comes to the products we regulate and the scientific research we carry out. And we want to share our progress with you.
Our FDA Voice blog gives FDA staff a chance to provide their unique take on policy and agency actions.
News releases and other communications also keep stakeholders and the public up to date on what we’re doing.
See a collection of recent blogs, news releases, and other materials below.
"...FDA will soon unveil a comprehensive Innovation Initiative. It will be aimed at making sure our regulatory processes are modern and efficient, so that safe and effective new technologies can reach patients in a timely fashion. We need to make sure that our regulatory principles are efficient and informed by the most up to date science. We don’t want to present regulatory barriers to beneficial new medical innovations that add to the time, cost, and uncertainty of bringing these technologies forward if they don’t add to our understanding of the product’s safety and benefits." —Scott Gottlieb, M.D., Commissioner of Food and Drugs
Learn more in the FDA Voice blog, How FDA Plans to Help Consumers Capitalize on Advances in Science.
Biologic and Drug Development
- FDA approves Cinqair to treat severe asthma
- FDA approves new psoriasis drug Taltz
- FDA approves new treatment for inhalation anthrax
- FDA expands use of Xalkori to treat rare form of advanced non-small cell lung cancer
- FDA approves first coagulation factor-albumin fusion protein to treat patients with hemophilia B
- FDA approves Briviact to treat partial onset seizures
- CBERâs laboratory quality system management helps keep biological product standards high
- Changing course: A new approach to opioid pain medication at FDA
- Building a modern generic drug review process
- Modernizing pharmaceutical manufacturing to improve drug quality: Ensuring a safe and adequate supply of drugs
Device Development
- FDA permits marketing of device that senses optimal time to check patientâs eye pressure
- Building a case for medical device interoperability: FDAâs call to action
- FDA outlines cybersecurity recommendations for medical device manufacturers
- FDA approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers
- FDA permits marketing of fecal continence restoration system
- FDA approves wearable defibrillator for children at risk for sudden cardiac arrest
- FDA allows marketing of cooling cap to reduce hair loss during chemotherapy
- FDA clears military traumatic wound dressing for use in the civilian population
- The case for quality: Working with stakeholders to improve the safety of medical devices for patients
- FDA allows marketing of the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid
Clinical Trials
- FDA and NIH release a draft clinical trial protocol template for public comment
- What is FDA doing to improve the health of African-Americans?
- 2016: The year of diversity in clinical trials
- Progress and collaboration on clinical trials
- FDA encourages diversity in clinical trials and advances health equity
- Making progress on demographic information and clinical trials
- FDA's Center for Devices and Radiological Health expedites safe start of U.S. clinical trials
Digital Healthcare
Personalized Medicine
- FDA launches precisionFDA to harness the power of scientific collaboration
- FDA taking genomic testing to the next level
- Advancing precision medicine by enabling a collaborative informatics community
- FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome
- FDA continues to tailor oversight for next generation sequencing
General News
- Clarifying what we mean when we talk about biomarkers: An NIH/FDA joint leadership council success
- Launching a new Natural History Grant Program: Building a solid foundation for rare disease treatments
- 'Leaning inâ on combination products
- Advancing Women's Health Research
- FDA 2015: A look back(and ahead)âPart 3: Food, tobacco, and antimicrobial resistance
- FDA 2015: A look back (and ahead) Part 2: Medical product safety and oversight
- FDA 2015: A look back (and ahead)âPart 1: Medical product innovation
- The merging of medical products: Enhancing review of therapeutic and diagnostic combination products
- FDA invests in innovative ways to communicate to Hispanics
- The times they are a changinââand so is FDA