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Ningbo Huize Commodity receives FDA warning for quality control failures
Ningbo Huize Commodity Company recently received a warning letter from the U.S. Food and Drug Administration over Current Good Manufacturing Practice (CGMP) violations.
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New study says The Real Cost smoking prevention program saves 587,000 youths from smoking
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.
FDA issued 18 warning letters to companies in August
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.
FDA reviews data manipulation in AveXis' new gene therapy drug for children
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.
FDA warning about the side effects of Miracle Mineral Solution
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.
FDA to unveil new warning labels for cigarettes
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.
FDA approvals of new drugs, biological products dip slightly in FY2019
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.
Some flavored e-liquid and hookah tobacco products to be removed
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.
Dynacure receives orphan drug designation for drug to treat Centronuclear Myopathies
DYN101, an investigational antisense medication for Centronuclear Myopathies (CNM), has received Orphan Drug Designation, according to the drug development company Dynacure.
FDA Update: electronic submissions statistics
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.
Drug-patent reform seeks accessibility, less data
As prescription drugs remain inaccessible to most, the notion of patent reform is seemingly settling into public discourse.
Republicans look to Fair Care Act of 2019 to improve health insurance system
Some in Congress are hoping the Republican sponsored Fair Care Act of 2019 will open the floodgates for Americans to buy health insurance.
Nektar Therapeutics, Bristol-Myers Squibb receive FDA breakthrough therapy designation
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.
EndBrainCancer Initiative urges support, offers amendments
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.
FDA policymaker to keynote hemp business summit
Leading authorities on hemp are set to gather next week in Portland, Oregon, in anticipation of learning more about upcoming regulations to the industry.
FDA Update: Mammography Procedure Numbers
Mammograms per year in the nation numbered more than 39.5 million as of Aug. 1, the U.S. Food and Drug Administration reports.
FDA issued 14 warning letters to companies in July
The U.S. Food and Drug Administration issued 14 warning letters in July that were sent to manufacturers and other companies found to have violated FDA regulations.
Despite Right to Try Act, ALS patients still desperately wait for fatal disease drug treatments
People afflicted with the deadly and crushing disease amyotrophic lateral sclerosis (ALS) are searching for some glimmer of hope in the shadow of promising drug treatments, however ALS patients do not currently have real access to these drugs, which are presently in trials.
Republican senators introduce innovation-driven drug-treatment bill; brace for resistance from FDA
Two Republican senators recently introduced a bill they claim would combat U.S. drug shortages and drive down the prices of drugs and medical devices by allowing patients to select treatments approved in other countries.
FDA issued 34 warning letters to companies in June
The U.S. Food and Drug Administration issued 34 warning letters in June that were sent to manufacturers and other companies found to have violated FDA regulations.