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AirXpanders, Inc. (ASX: AXP), a medical device company focused on the design, manufacture, sale and distribution of the AeroForm® Tissue Expander System, announced that the company has submitted a Special 510(k) pre-market notification to the US Food and Drug Administration (FDA) for a Smooth Shell version of the AeroForm Tissue Expander System.
The U.S. Food and Drug Administration plays an important role in helping to address the high cost of medicines through the development of science-based policies that can improve competition and patient access to safe and effective, high-quality and lower cost generic drugs, biosimilars and interchangeable biologics.
Regis Technologies, a contract development and manufacturing organization for small molecule active pharmaceutical ingredients, earned perfect results from its April 2019 FDA inspection.
Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies designed to capture more data to better understand effects of prescription drugs in pregnant and nursing women
A bill proposing the right to try adult stem cell treatments was introduced in the North Carolina House on April 22.
The Regulatory Education for Industry Annual Conference will be held May 29-30 at the Revere Hotel, 200 Stuart St., Boston.
Center for Tobacco Products incorporates machine learning platform to assist toxicology research
Phillips-Medisize, a Molex company, today announces the Little Rock, Arkansas facility is fully compliant with the Current Good Manufacturing Practice (CGMP) regulations enforced by the FDA. The facility is FDA 21 CFR part 820 compliant.
The number of vacancies on U.S. Food and Drug Administration advisory committees ticked upward during the final months of 2018, according to the agency’s most recent numbers.
As part of the U.S. Food and Drug Administration’s mission to protect the public health, outlined in our Medical Device Safety Action Plan, we are committed to continuing to strengthen and modernize how we take action to address device safety issues that emerge in the post-market in a more timely and effective way.
Voluntary recalls are one of the most important safety tools overseen by the U.S. Food and Drug Administration.
Health research group Public Citizen's founder, Sidney Wolfe, believes a moratorium on opioid production is necessary because new opioids and reformulations of opioids have more known risks than benefits.
Fee rates and payment instructions for companies submitting new medical device applications to the federal Food and Drug Administration have been released for fiscal year 2019, which began on Oct. 1, 2018.
Encourages Florida Policymakers to Consider Alternatives to Rising Out-of-Pocket Costs
A labeling change order was issued to Sprout Pharmaceuticals last week by the Food and Drug Administration concerning its drug Addyi (flibanserin).
Taking a dietary supplement – like vitamins, minerals, or herbs – has become a daily routine for many Americans.
