We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Topics » Pharmaceuticals » Quality

Quality
%{topic} RSS Feed RSS

Academics, Pharmacists Call for Drug Quality Rating System

June 2, 2020
A group of U.S. academics and pharmacists has proposed a quality rating system for prescription drugs that would allow bulk buyers to assess the quality of drugs before they make purchases. Read More

Academics, Pharmacists Call for Drug Quality Rating System

June 2, 2020
A group of U.S. academics and pharmacists has proposed a quality rating system for prescription drugs that would allow bulk buyers to assess the quality of drugs before they make purchases. Read More

CDER Outlines CGMPs — and Exemptions — for Outsourcing Facilities

February 3, 2020
CDER spelled out current good manufacturing practices for drug compounders that register as outsourcers in a new draft guidance — and noted when the FDA does not intend to take regulatory action. Read More

CDER Outlines CGMPs — and Exemptions — for Outsourcing Facilities

January 31, 2020
The guidance reflects FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers,” the agency said. Read More

CDER Outlines CGMPs — and Exemptions — for Outsourcing Facilities

January 23, 2020
CDER spelled out current good manufacturing practices for drug compounders that register as outsourcers in a new draft guidance — and noted when the FDA does not intend to take regulatory action. Read More

Drug Shortage Task Force Finds ‘A Broken Marketplace,’ Say Sharpless, Woodcock

November 14, 2019
A key cause of U.S. drug shortages is the market’s failure to reward well-developed quality management systems, according to an analysis by an FDA-led interagency task force. Read More

Drug Shortage Task Force Finds ‘A Broken Marketplace,’ Say Sharpless, Woodcock

October 29, 2019
A key cause of U.S. drug shortages is the market’s failure to reward well-developed quality management systems, according to an analysis by an FDA-led interagency task force released on Tuesday. Read More

FDA Proposes Voluntary Consensus Standards to Help Speed Drug Reviews

March 5, 2019
CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews. Read More
FDA_Logo_Black_2016.gif

FDA Defends Its Oversight of Generic Drug Quality

March 1, 2019
Gottlieb and Woodcock spoke out against the media’s questioning of generic drug quality, saying they believe that the data analysis-based reports are faulty. Read More

FDA Defends Its Oversight of Generic Drug Quality

February 22, 2019
FDA Commissioner Scott Gottlieb and CDER director Janet Woodcock rallied Friday against recent media claims that generics are of lesser quality than brand name drugs, outlining methods the agency takes to protect their quality and effectiveness. Read More
FDA_Logo_Blue_2016.gif

FDA Proposes Voluntary Consensus Standards to Help Speed Drug Reviews

February 21, 2019
The standards would be listed in a publicly searchable database. Read More

FDA Proposes Voluntary Consensus Standards to Help Speed Drug Reviews

February 13, 2019
CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews. Read More
Previous 1 2 3 4 5 6 7 8 9 … 96 97 Next

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • AstraZeneca

    AstraZeneca Withdraws Imfinzi’s Bladder Cancer Indication

  • CE mark

    Cue Health’s COVID-19 Test Receives CE Mark

  • Sanofi-Regeneron_Logos.png

    Sanofi’s and Regeneron’s Libtayo Wins FDA Approval for NSCLC

  • PerkinElmer logo

    PerkinElmer’s Rapid Point-of-Care COVID-19 Test Cleared in Europe

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing