Saturday, December 7, 2019

Saturday, December 7, 2019

Latest News

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.

FDA looks to modernize on food safety

FDA acting commissioner Norman Sharpless and deputy commissioner for food policy and response Frank Yiannas released a statement on the changes technology has made on how Americans receive their food.

AMERICAN NATIONAL STANDARDS INSTITUTE: ANSI/ANAB Accredits Quality Certification Services to Certify Foreign Food Supplies under U.S. FDA-FSMA Program

The American National Standards Institute (ANSI), coordinator of the U.S. voluntary standardization system, has accredited Florida Certified Organic Growers, Inc. DBA Quality Certification Services in accordance with the international standard ISO/IEC 17065, Conformity assessment—Requirements for bodies certifying products, processes, and services; and pertinent certification scheme requirements and regulations under the U.S. Food & Drug Administration (FDA)'s Food Safety Modernization Act, or FSMA. ANSI's conformity assessment accreditation programs were reorganized in December 2018 under the ANSI National Accreditation Board(ANAB) brand, a wholly owned subsidiary of ANSI.

Reforms could tackle high prices imposed by pharmaceutical industry

Whistleblowers are claiming that pharmaceutical companies are bribing doctors to sell their drugs so they can raise the prices on them.

VIZIENT, INC.: Expresses Concern with FDA Policy on Naming of Biologic Medications

Vizient, Inc. today submitted comments to the Food and Drug Administration (FDA) in response to its published draft guidance on the nonproprietary naming of biological products.

HI-TECH PHARMACEUTICALS, INC.: Sues The FDA For "Its Campaign of Intimidation"

Hi-Tech Pharmaceuticals sued the FDA May 2nd, 2019 in Federal Court- Case 1:19-cv-01268, claiming the agency bypassed standard rule-making procedures in favor of a campaign of intimidation to try to force companies to destroy their products containing 2-Aminoisopheptane, or DMHA.

FDA to host hearing on cannabis products

The FDA will have a hearing on scientific data and information about products containing cannabis or cannabis-derived compounds on May 31 from 8 a.m. to 6 p.m.

SYSTECH INTERNATIONAL: Optimal Solution team selected for FDA DSCSA Pilot Program

"The Optimal Solution" is a team of seasoned industry innovators cooperatively leveraging their expertise to demonstrate interoperability at scale in the pharma supply chain ecosystem. Team members include: RXTransparent, Systech, T-Systems, FarmaTrust, Cryptowerk and CalQLogic.

FDA Reporter