Saturday, August 24, 2019

Saturday, August 24, 2019

Latest News

FDA studying ways to improve medical device safety

Silicone breast implants, metal rods to stabilize broken bones, heart valves made from the tissues of pigs and cows—modern medical technology is continually developing devices to implant in human bodies to improve health, quality of life, or appearance.

FDA clears Selvita to conduct Phase 1 study for acute myeloid leukemia

The FDA will allow Selvita to conduct a Phase 1 study on an Investigational New Drug for acute myeloid leukemia or high-risk myelodysplastic syndrome.

U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices

Artificial intelligence and machine learning have the potential to fundamentally transform the delivery of health care. As technology and science advance, we can expect to see earlier disease detection, more accurate diagnosis, more targeted therapies and significant improvements in personalized medicine.

U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs

We’ve long recognized that compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product.

U.S. FOOD AND DRUG ADMINISTRATION: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

In recent years, we’ve seen a growing interest in the development of therapies and other FDA-regulated consumer products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD).

FDA approves new drug for multiple sclerosis

People who suffer from multiple sclerosis (MS) have a new hope of slowing the progression of their disease with the U.S. Food and Drug Administation’s (FDA) approval of a new drug.

U.S. FOOD AND DRUG ADMINISTRATION: FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products

Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, while progressing the agency’s commitment to help advance legitimate stem cell product development under existing agency regulations

U.S. FOOD AND DRUG ADMINISTRATION: FDA’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adults

Statement from FDA Commissioner Scott Gottlieb, M.D., and Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on FDA’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adults

U.S. FOOD AND DRUG ADMINISTRATION: The agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue

Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue

FDA OK'd 272 drugs in March

The U.S. Food and Drug Administration approved 272 drug products in March, according to a list the agency published on Thursday.

EAS CONSULTING GROUP, LLC: EAS Expands GRAS Capabilities with Toxicology, CRO Services

EAS Consulting Group, LLC, leaders in FDA regulatory consulting services is pleased to announce the expansion of capabilities and comprehensive services offered to clients seeking to file a Generally Recognized as Safe (GRAS) and other submissions documenting food safety to the U.S. Food and Drug Administration (FDA).

U.S. FOOD AND DRUG ADMINISTRATION: FDA takes new steps to increase access to adverse event report data for medical products used in animals

The U.S. Food and Drug Administration announced it is making available online the adverse event reports related to animal drugs and medical devices used in animals.

Three-minute 'Theta Burst' treatment cleared by FDA

The FDA has cleared a new treatment for major depressive disorder.

FDA gives clearance for Scientific Analytics and Hospital for Special Surgery for computer-vision collaboration

The FDA gave 510(k) medical device designation to Scientific Analytics (SAI) for DARI Health, a computer-vision-powered motion analysis technology.

U.S. FOOD AND DRUG ADMINISTRATION: New opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids

Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids

SUN PHARMACEUTICAL INDUSTRIES LTD.: Sun Pharma Launches Ready-to-Infuse INFUGEM in the U.S.

INFUGEM™ (gemcitabine in sodium chloride injection) is the first and only chemotherapy product in a premixed, ready-to-infuse formulation

FDA Reporter