Premarket tobacco product applications (PMTAs) now have new requirements for the content, format and Food and Drug Administration (FDA) review and communication procedures after the FDA issued a proposed rule in their efforts to lessen the number of e-cigarette and other tobacco products on the market.
The opioid crisis has become such a public health crisis that there is now a Prescription Opioid and Heroin Epidemic Awareness Week to focus on the dangers of opioid addiction as well as treatment options treatment – which includes access to Naloxone.
Draft guidance from the U.S. Food and Drug Administration (FDA) on real-world data (RWD) and real-world evidence (RWE) was released in May to mixed reaction from stakeholders.
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The U.S. Food and Drug Administration (FDA) and the U.S. Center for Disease Control (CDC) are relying on myths to scare people away from vaping, according to Alex Berezow of the American Council on Science and Health (ACSH).
The U.S. Food and Drug Administration (FDA) removed the alcohol contraindication from Addyi, the only FDA-approved treatment for pre-menopausal women for Hypoactive Sexual Desire Disorder (HSDD).
The Food and Drug Administration (FDA) has granted a submission for a Breakthrough Device designation from Prescient Metabiomics for its LifeKit Prevent Colorectal Neoplasia Test for the early detection of colon polyps and colon cancer.
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Ningbo Huize Commodity Company recently received a warning letter from the U.S. Food and Drug Administration over Current Good Manufacturing Practice (CGMP) violations.
The Food and Drug Administration’s “The Real Cost” campaign prevents 587,000 youth from starting smoking and saves more than $53 billion, according to a new study in the American Journal of Preventive Medicine.
The Miracle Mineral Solution has been a concern of the Food and Drug Administration since 2010. Once again, the FDA is warning people not to buy these products because, once the solution is mixed, it develops into a harmful bleach, causing a variety of serious and potentially life-threatening side effects.
The new Vital Signs Measurement System from DynoSense Corp. was approved by the Food and Drug Administration on Aug. 13.
Warning letters were issued by the U.S. Food and Drug Administration to four companies who do not have the required marketing authorization for 44 flavors of e-liquid and hookah tobacco products.
DYN101, an investigational antisense medication for Centronuclear Myopathies (CNM), has received Orphan Drug Designation, according to the drug development company Dynacure.
The U.S. Food and Drug Administration has granted breakthrough therapy designation for bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb's Opdivo (nivolumab) based on clinical data from the 2019 American Society of Clinical Oncology (ASCO) annual meeting.
New guidelines proposed by the Food and Drug Administration are receiving support by the EndBrainCancer Initiative (EBCI). The new guidelines focus on diversity in clinical trials.
The Food and Drug Administration (FDA) recently released guidelines for safety reporting for combination products that clarify which companies and products must abide by the final rules on post-marketing safety reporting (PMSR) requirements and how exactly to do so.
A December 2018 decision by the Food and Drug Administration (FDA) to block the final approval of a product from Braeburn Pharmaceuticals for the treatment of opioid use disorder has been vacated.
The CoolTone device from Allergan received Food and Drug Administration approval for use in improving abdominal tone and strength. CoolTone is already approved for strengthening, toning and firming of the buttocks and thighs.
A New Drug Application (NDA) was resubmitted by Correvio Pharma Corporation to the Food and Drug Administration for the approval of Brinavess.
The Food and Drug Administration approved drug company Allergan’s supplemental biologics application for Botox for patients 2-17 years old with upper limb spasticity.
The VIVO (View Into Ventricular Onset) system from Catheter Precision has been cleared by the Food and Drug Administration for market release in the U.S.