Representative Jim Struzzi (R-IN) introduced two new bills that have the potential to regulate cannabidiol (CBD) and kratom sales in Pennsylvania.
The U.S. Food and Drug Administration held 10 public meetings related to the review of license applications for drugs and biologics during the first three quarters of fiscal-year 2019, the regulatory agency reported last month.
New drug and biological product application filings were down slightly in the first three quarters of the current fiscal year, compared to the same period in the previous year, according to data released by the U.S. Food and Drug Administration.
For millions of people who suffer from debilitating diseases, experimental gene therapies hold much promise.
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 U.S. Food and Drug Administration issued 18 warning letters in August that were sent to manufacturers and other companies found to have violated FDA regulations.
One month after the approval of a new gene therapy drug for a rare disease in children, the Food and Drug Administration was informed by AveXis Inc., the product’s manufacturer, about a data manipulation issue.
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 U.S. Food and Drug Administration is planning on unveiling a new rule where they will implement new health warnings in regard to cigarette packages.
New drug and biological product approvals were down slightly in the first three quarters of the current fiscal year, compared to the same period in the previous year, according to data released by the U.S. Food and Drug Administration.
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.
Electronic regulatory submissions sent to the U.S. Food and Drug Administration have increased year-by-year since the electronic system was launched in 2009, the FDA reports.
As prescription drugs remain inaccessible to most, the notion of patent reform is seemingly settling into public discourse.
Some in Congress are hoping the Republican sponsored Fair Care Act of 2019 will open the floodgates for Americans to buy health insurance.
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.
Leading authorities on hemp are set to gather next week in Portland, Oregon, in anticipation of learning more about upcoming regulations to the industry.