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 » Regulatory Affairs

Regulatory Affairs
%{topic} RSS Feed RSS

FDA Planning Phased Transition to New Cures Act Drug Development Tool Qualification Scheme

June 8, 2017
The FDA is planning to transition to a new drug development tool qualification process — as required by the 21st Century Cures Act — for clearing the use of biomarkers, clinical outcomes assessments and other methods to aid regulatory review. Read More

FDA Requests Endo Remove Opioid Painkiller Opana ER From the Market After Reports of Abuse

June 8, 2017
The FDA requested that Endo Pharmaceuticals voluntarily remove its opioid painkiller Opana ER from the market, saying its benefits may no longer outweigh its risks of abuse — the first time the agency has taken steps to remove a currently marketed opioid from sale. Read More

FDA Reauthorization Advances to House Floor

June 7, 2017
The House Energy and Commerce Committee voted 54-0 on Wednesday to advance the FDA’s five-year user fee reauthorization package to the floor of the House — following a lengthy debate, more on the rising cost of prescription drugs than on the fee programs at the heart of the bill. Read More

Judge Puts Amgen’s Exclusivity Lawsuit Against the FDA on Hold

June 7, 2017
The FDA agreed to make a decision on the resubmitted request by June 26. Read More

Express Scripts Claims ‘Profiteering’ in Suit Against Overdose Treatment Manufacturer

June 7, 2017
The lawsuit claims Kaleo owes administrative fees that increased at the same time as Evzio’s prices. Read More

Belcher Pharma Petitions FDA to Alter Epinephrine Warning Label

June 7, 2017
The current labeling requirements were imposed in 1986 and are no longer accurate. Read More

WHO Updates its Essential Medicines List, Adding Drugs for Hep C, HIV & New Antibiotics

June 6, 2017
The World Health Organization published its biennial update to its list of essential medicines, adding therapies for hepatitis C, HIV and leukemia, as well as new advice on combating antimicrobial drug resistance. Read More

Ohio Becomes Second State to Sue Opioid Manufacturers

June 6, 2017
The suit claims the manufacturers misled prescribers on the addictiveness of their products. Read More
GavelwithBaseBW.gif

SCOTUS Decision on Printer Cartridges Could Impact Drug Imports

June 6, 2017
The court held that after an individual product is sold, all of the patent rights on that product are exhausted. Read More

EMA, Experts Take on Brexit Questions

June 6, 2017
The European Medicines Agency answered the most pressing questions related to the United Kingdom’s exit from the European Union, making it clear UK-made products would be subject to import quality inspections — and that companies in the UK may have to relocate their pharmacovigilance work and personnel to comply with regulations. Read More

Warning Letter Roundup: Variety of GMP Repeat Violations Garner FDA Warnings

June 6, 2017
Significant GMP violations and repeating problems at U.S. companies across the drug supply chain lead the FDA to issue warning letters, including a lack of product testing at an Oklahoma drug manufacturer. Read More

As Gottlieb Takes the Helm at FDA, Expect Focus on Workforce

June 6, 2017
FDA Commissioner Scott Gottlieb spent the early weeks of his tenure in the agency’s top job laying out his priorities before senior FDA staff and members of Congress and announcing the agency’s hiring freeze had officially been lifted. Read More
Previous 1 2 … 443 444 445 446 447 448 449 450 451 … 821 822 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

  • WhiteHouse.gif

    President Biden Issues Executive Order on U.S. Supply Chain

  • roche.gif

    Priority Healthcare Settles Diabetes Test Lawsuit with Roche for $43 Million

  • Effective text

    Pfizer/BioNTech Vaccine Equally Effective for All Age Groups, Israeli Study Says

  • Siemens Healthineers logo

    Siemens Healthineers’ COVID-19 Antigen Lab Test Receives CE Mark

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