Latest News

FDA expanding its drug approval process by incorporating ‘real world’ data and evidence

The U.S. Food and Drug Administration is using some new tools in its drug approval process and at least one prominent industry leader is giving the government entity a thumb’s up.

AVA president says parents should play of a role in banning sales of vape products to minors

The American Vaping Association says FDA fear-mongering on vaping products for minors could end up making the products more enticing.

Annual volume of FDA-regulated imported goods up 5-10%

Products imported into the United States that require screening by the Food and Drug Administration continue to increase at a rate between 5 and 10 percent annually, the FDA reports.

Promising cancer treatment awaits approval

New cancer treatments known as chimeric antigen receptor (CAR) T cell therapy are awaiting approval from the Centers for Medicare and Medicated Services (CMS) to be financially covered for outpatients in cancer centers or clinics.

Former FDA head Scott Gottlieb appointed to Pfizer’s board of directors

Former Food and Drug Administration Commissioner Scott Gottlieb joined pharmaceutical corporation Pfizer’s board of directors on June 27, after stepping down from the FDA in April.

24 medical devices OK’d by FDA so far this year

Twenty-four medical devices have been approved as of June 18 for prescribed uses, according to the federal Food and Drug Administration.

Doctor says FDA should do more to combat opioid crisis

The Food and Drug Administration unveiled yet another draft guidance on opioid addiction, but one doctor remains unimpressed.

Drug companies want clarity on FDA guidelines for bispecific antibodies

A group of major pharmaceutical companies is asking the US Food and Drug Administration to consider changes to the agency's guidelines on developing bispecific antibodies.

Flaws in the system allow Clinicaltrials.gov to host illegal trails

The website Clinicaltrials.gov is home to a broad spectrum of clinical trials, both legitimate and illegal, according to FDAMap.com.

FDA OK'd 227 drugs in June

The U.S. Food and Drug Administration approved 227 drug products in June, according to an online list the agency updated this week.

Doctors, not FDA, should be empowered to deal with opioid crisis, association says

The Food and Drug Administration recently unveiled a new draft guidance for tackling opioid addiction, and scheduled a public hearing for Sept. 17 to discuss the crisis.

‘This is nuts’: FDA program set to help doctors navigate bureaucracy

Health care experts are expressing doubts about the FDA’s new call center, Project Facilitate, which is designed to assist physicians treating cancer patients.

Cannabis regulation not in FDA jurisdiction, industry expert says

The Food and Drug Administration has been gathering comments on how to regulate cannabis products, but a cannabis industry expert says FDA should lay off and let states do their jobs.

U.S., 27 EU nations join drug inspection accord

As of this month, 27 European nations are part of a mutual recognition agreement that allows regulatory agencies such as the U.S. Food and Drug Administration to rely on drug inspection data conducted within member nations.

Should FDA be allowed to share in the profits during its approval process?

A Hawaii doctor opined in a column if the Food and Drug Administration should share in pharmaceutical and medical research profit.

FDA Update: Which drugs are in short supply?

The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.

Physician praises FDA plans to further assist doctors obtain experimental cancer treatments

WASHINGTON, D.C. -- A physician has applauded a new FDA program that aims to simplify the process doctors use to offer non-approved cancer treatments to patients.

Emerging biotech firms rival big pharma in new drug development, study finds

Emerging biotech companies developed nearly two-thirds of the new drug therapies approved last year in the United States, according to a new study by the pharmaceutical research company Iqvia.

Are price controls the answer when it comes to gene therapy drugs?

Some believe with the advent of gene therapy, the future of medicine has been seen.

Hundreds of Thousands of Deaths a Year a 'Call to Action,' FDA Says on World Food Safety Day

The first World Food Safety Day was held on June 7 with deputy commissioner for food policy and response Frank Yiannas representing the Food and Drug Administration.

FDA Reporter