Tuesday, November 12, 2019

Tuesday, November 12, 2019

Latest News

Proposed FDA vaping regulations are 'extensive, outdated,' AVA president says

Former U.S. Food and Drug Administration (FDA) commissioner David Kessler drew attention last week when he said he thought Juul and other popular vaping manufacturers would be forced to leave the market under proposed FDA rules.

FDA vaping regulations will hurt consumers, independents, CASAA says

As FDA deadlines approach for regulations on electronic tobacco products, observers say the industry is in for a period of change and consolidation.

FDA issued 13 warning letters in October

The U.S. Food and Drug Administration (FDA) issued 13 warning letters in October that were sent to manufacturers and other companies found to have violated FDA regulations.

FDA needs more oversight of regenerative medicine, Penn professor says

For nearly 20 years, regenerative medicine such as cell and gene therapies have gradually shown much promise in repairing or replacing damaged and infected cells, tissues and organs in order to cure ailments including organ failure, spinal cord injuries, multiple sclerosis and other traumatic wounds and diseases.

Former FDA official responds – in part – to Taxpayers Protection Alliance's suggested reforms

Dr. David Gortler, former Food and Drug Administration (FDA) official, drug safety and FDA regulatory affairs expert and pharmacology professor, responds to the Taxpayers Protection Alliances’ (TPA) list of recommendations to improve business strategies released Oct. 3.

FDA Update: 2019 animal product recalls

The U.S. Food and Drug Administration recalled 28 animal products from January through September of 2019, the agency reported.

FDA Update: recent animal drug approvals

Federal law dictates that drug companies can’t manufacture and market medicines for animals unless they get the approval of the U.S. Food and Drug Administration.

Taxpayers Protection Alliance recommends FDA reforms

The U.S. Food and Drug Administration (FDA) holds primary responsibility for approving and regulating various human and animal prescription drugs, medical and tobacco products and the nation’s food supply.

FDA unveils guidances for digital health care

The U.S. Food and Drug Administration (FDA) recently unveiled a series of guidances about utilizing digital health tools to help patients.

Pressure mounts on politicians, FDA to react to vaping-related illnesses, deaths

According to an article on the Forbes website, vaping will impact two sectors of the financial markets the most: Big Tobacco and marijuana stocks.

FDA issued 19 warning letters to companies in September

The U.S. Food and Drug Administration issued 19 warning letters in September that were sent to manufacturers and other companies found to have violated FDA regulations.

Vaping illnesses caused by illegal substances, AVA says

As more people become ill from using vaping products, government authorities are beginning to take a hard look at e-cigarettes.

FDA Update: international cooperative arrangements

Since the year 2000, the U.S. Food and Drug Administration has entered into 40 cooperative arrangements involving foods, pharmaceuticals or medical devices with foreign governments or partners in other nations, according to the FDA.

Critics say the latest attempt by Congress to reign in prescription drug prices may not work

The Prescription Drug Pricing Reduction Act (PDPRA) is expected to work its way through Congress this fall.

FDA Update: Import refusals in August

The U.S. Food and Drug Administration barred 485 shipments from entering the United States in August, according to FDA import records.

Trump administration's flavored vaping ban doesn't go far enough, bipartisan group says

The Trump administration’s move to ban certain flavors of e-cigarettes and vaping devices either goes too far or doesn’t go far enough, according to those on opposite sides of the debate.

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.

FDA Reporter