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127 articles with FDA
Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway
Earlier this week, the FDA announced new steps to modernize FDA's 510(k) clearance pathway, used for low- to moderate-risk devices that are substantially equivalent to a device already on the market, known as a predicate device.
Sciton, Inc. announced today that the FDA has advised the company that it appears that Sciton has satisfactorily addressed all items raised by the FDA in its July 24, 2018 "It Has Come to Our Attention" letter.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA's expanded access program
Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for patients with serious or immediately life-threatening diseases who are unable to access products through clinical trials.
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma
One of our ongoing priorities is making sure consumers have access to the medicines that help keep them healthy.
Shoulder Innovations announced today that they have received FDA clearance for their InSet Humeral Short Stem System.
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency's continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation
Over the past several months, we've continued to voice our concerns about the growing epidemic of youth e-cigarette use.
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency's approval of Dsuvia and the FDA's future consideration of new opioids
The crisis of opioid addiction is an issue of great concern for our nation. Addressing it is a public health priority for the FDA.
Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA's efforts to prevent future outbreaks
Earlier this year, we experienced the largest E. coli O157:H7 outbreak the country has seen in the last decade, leaving hundreds sick and claiming the lives of five people who consumed contaminated romaine lettuce.
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency's efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths
With the number of overdose deaths from prescription and illicit opioids doubling from 21,089 in 2010 to 42,249 in 2016, it's critical that we continue to tackle this human tragedy from all fronts – including, and importantly, looking at new ways to increase the availability of naloxone.
Alphamab Oncology's HER2 bispecific antibody KN026 gained US IND approval; phase I clinical trial started in China
Alphamab Oncology announced that it has received US FDA's IND approval for its proprietary HER2 bispecific antibody (product code: KN026), and KN026 is anticipated to enter clinical development later in the US.
Statement by FDA Commissioner Scott Gottlieb, M.D., on preparations for the upcoming flu season and vaccinations
This week marks the official start of "flu season" for 2018-2019. The FDA, along with its partners across the Department of Health and Human Services, has been working throughout the year to prepare the development of a safe, effective flu vaccine for the season.
HighTide Therapeutics Receives Fast Track Designation from the U.S. FDA for HTD1801 Treating Primary Sclerosing Cholangitis
HighTide Therapeutics Inc. announced that the U.S. FDA has granted Fast Track Designation to its investigational new drug, HTD1801, for the treatment of patients with primary sclerosing cholangitis (PSC).
Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes
Consumers should be able to know at a quick glance what type of product they're purchasing for themselves and their families. Implementing clear and transparent food labels and claims is an issue I've made a high priority.
OrthoXel™ Evolving Fracture Fixation Announce FDA 510(k) Clearance for new Apex Femoral Nailing System
OrthoXel™ is delighted to announce that the new Apex Femoral Nailing System has been granted US FDA 510(k) clearance, following regulatory clearances and first clinical implantations of the Apex Tibial Nailing System earlier this year.
Stryker announced today that it has received FDA 510(k) clearance to market the SpineJack Implantable Fracture Reduction System.
MT.DERM GmbH, Berlin, Germany, is excited to announce its expansion into the US market of its medical microneedling device, Exceed under the brand amiea med, exclusively available to healthcare professionals.
FDA Issues Statement Reaffirming the Positive Benefit-Risk Profile of NUPLAZID® (pimavanserin) for Patients with Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis
FDA analysis finds no new or unexpected safety risks associated with NUPLAZID
Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of 'The Real Cost' Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids
In recent days, I've warned about an epidemic of use of e-cigarettes among teens. We're in possession of data that shows a disturbingly sharp rise in the number of teens using e-cigarettes in just the last year.
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA's ongoing investigation into valsartan impurities and recalls and an update on FDA's current findings
Millions of Americans take medication daily to control their blood pressure. We recently found that some generic versions of one medication, valsartan, contain an impurity that doesn't meet FDA's safety standards.
Kadima Neuropsychiatry Institute Among First Centers to Provide Novel OCD Treatment Recently Approved by the FDA
The San Diego center has been conducting research with the innovative brain stimulating technology