U.S. FOOD AND DRUG ADMINISTRATION: Overview of FDA’s Perinatal Health Center of Excellence: Development and Validation of Predictive Systems
Overview of FDA’s Perinatal Health Center of Excellence: Development and Validation of Predictive Systems
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GILEAD SCIENCES, INC.: Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. Food and Drug Administration This Year
Gilead Sciences, Inc. (NASDAQ: GILD) announced that at a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company provided an update about the investigational, oral, selective JAK1 inhibitor filgotinib.
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The Food and Drug Administration recently unveiled a new draft guidance for tackling opioid addiction, and scheduled a public hearing for Sept. 17 to discuss the crisis.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.
National Center for Health Research wants clearer information disseminated on device predicates
The nonprofit National Center for Health Research (NCHR) said it believes the FDA should make patients aware that devices in the 510 (k) program have not been sufficiently tested on humans through trials, like drugs are tested before being put on the market.
U.S. FOOD AND DRUG ADMINISTRATION: Statement on agency’s efforts to increase transparency in medical device reporting
In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of important steps to update its Medical Device Reporting (MDR) Program, one of the tools the FDA uses to monitor device performance, detect potential device-related safety concerns or signals and contribute to the benefit-risk assessment of these products.
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.
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TRINETX: Applauds House Appropriations Committee for Supporting Use of Real-World Evidence in House Agriculture-FDA Spending Bill
TriNetX, the global health research network that revolutionizes clinical research and enables discoveries through the generation of real-world evidence (RWE), praised the House Appropriations Committee for approving its fiscal year 2020 Agriculture, Rural Development, FDA, and Related Agencies bill which includes support for the use of RWE in regulatory decision making.
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.
Project Facilitate will help physicians access unapproved therapies
A new pilot program, Project Facilitate, was announced last week by the Food and Drug Administration to help oncology health-care professionals access unapproved therapies for their cancer patients.
FDA to shut down secret recording program
When the FDA made the announcement, it said it would open past records within weeks. So why did the FDA have such a policy and why was it secret?
FDA to host conference in London
The FDA Drug Approval Process conference in London will provide an overview of procedures and requirements for the U.S. drug approval process.
Senate introduces health-care package with biosimilars boost
Bipartisan draft legislation was presented by the Senate Committee on Health, Education, Labor and Pensions (HELP) and chairman Lamar Alexander (R-TN) and Patty Murray (D-WA) that includes proposals featuring the use of biosimilars to lower health care costs.
Arizona doctor disagrees with FDA papers that claim agency should be indepedent
Seven former Food and Drug Administration commissioners suggested in a couple of articles that the FDA should become an independent agency
Health policy expert rejects suggestion of FDA independence
Two papers written by seven former FDA commissioners suggest the organization should become an independent agency.
CCHF president speaks out on FDA drug approval process
Citizensʼ Council for Health Freedom Media president Twila Brase says the current FDA drug approval process is too long and expensive.
Congress must consider legislation to allow fast track approval of drugs available in other developed countries: researcher
Congress should work on legislation allowing the FDA to fast-track the approval of some drugs already on the market in other developed countries, according to one researcher attached to a west coast free market think tank.