Thursday, September 19, 2019

Thursday, September 19, 2019

Latest News

New legislation proposed to regulate Pennsylvania CBD and kratom sales

Representative Jim Struzzi (R-IN) introduced two new bills that have the potential to regulate cannabidiol (CBD) and kratom sales in Pennsylvania.

FDA held 10 drug application meetings in first 9 months of FY 2019

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.

Applications for new drugs, biological products dip slightly in FY2019

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.

Taxpayer Protection Alliance: Get behind gene therapy revolution

For millions of people who suffer from debilitating diseases, experimental gene therapies hold much promise.

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.

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 Reporter