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Saturday, December 7, 2019

Saturday, December 7, 2019

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National Center for Health Research wants clearer information disseminated on device predicates

By Keri Carbaugh | Jun 29, 2019

U.S. FOOD AND DRUG ADMINISTRATION: Statement on agency’s efforts to increase transparency in medical device reporting

By Press release submission | Jun 24, 2019

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

By John Severance | Jun 22, 2019

Latest News

TRINETX: Applauds House Appropriations Committee for Supporting Use of Real-World Evidence in House Agriculture-FDA Spending Bill

By Press release submission | Jun 14, 2019

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?

By John Severance | Jun 13, 2019

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

Project Facilitate will help physicians access unapproved therapies

By Keri Carbaugh | Jun 12, 2019

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

By John Severance | Jun 6, 2019

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

By Keri Carbaugh | Jun 5, 2019

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

By Keri Carbaugh | May 30, 2019

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

By John Severance | May 22, 2019

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

By John Severance | May 22, 2019

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

By John Severance | May 16, 2019

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

By John Breslin | May 15, 2019

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

By Keri Carbaugh | May 13, 2019

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

By Press release submission | May 11, 2019

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

By Kyla Asbury | May 7, 2019

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

By Press release submission | May 7, 2019

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"

By Press release submission | May 3, 2019

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

By Keri Carbaugh | May 2, 2019

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

By Press release submission | Apr 25, 2019

"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.

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