New Tool: ProSource
Checkout our packaging and processing solutions finder, ProSource.
Design & Materials
Machinery
Sustainability
Logistics
Industry News
Search
Article
Blog
Company
Document
Media Gallery
News
Page
Podcast
Product
Video
Webinar
Beverage
Industries
Industry News
Regulatory
Logistics
Machinery
Podcasts
Quick Hits
Supplier News
Take Five
Webinars
Enter search phrase
Search
1,213 Results
Type: News
Section: Industry News > Regulatory
Regulatory
FDA Issues Draft Guidance for Biosimilar Products Labeling
The guidance explains what relevant data and information from the reference product labeling should be incorporated into biosimilar and interchangeable biosimilar product labeling.
November 10, 2023
Regulatory
FDA Issues Drug Development Benefit-Risk Assessment Guidance Document
U.S. Food and Drug Administration
The agency has released its “Benefits-Risk Assessment for Human Drug and Biological Products” final guidance to provide a clearer understanding of the FDA's decision-making context and benefit-risk considerations in drug development.
October 23, 2023
Regulatory
FDA Issues Final Guidance for Use of ISO 10993-1 for Medical Devices
FDA
The document provides further clarification and updated information on the use of International Standard ISO 10993–1, “Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process.”
September 14, 2023
Regulatory
FDA Extends Enhanced Drug Distribution Security Requirements Deadline
The agency has announced a one-year delay in the DSCSA requirements for system-wide electronic interoperable systems to be put in place and how to request a waiver, exception, or exemption.
August 29, 2023
Regulatory
FDA, DEA Taking Action to Rectify Prescription Stimulants Shortage
The agencies recently sent a joint letter to manufacturers to confirm they are working to increase their production of the drugs and, if they’re not, to do something about.
August 15, 2023
Logistics
HDA Traceability Seminar (Aug 29-31, 2023) and Webinar Series
Healthcare Distribution Alliance (HDA)
With Nov. 2023 approaching, HDA is holding its in-person Traceability Seminar two months early—in August—in Washington D.C., after its 3-part summer webinar series, covering tech solutions, industry recommendations for DSCSA enforcement, and more.
June 27, 2023
Regulatory
FDA Issues Pediatric Drug Development Draft Guidance
FDA
The new draft guidance assists industry members in obtaining the data and information necessary to support the approval of drug products in pediatric populations.
May 24, 2023
Medical Device/Packaging
RRD Simplifies Medical Device Recall Notices
R.R. Donnelley & Sons Co. (RRD)
Speed, patient safety, and compliance are key drivers in a new recall notices solution designed to support medical device companies and their need for immediate response.
May 15, 2023
Regulatory
FDA Taking Steps to Advance Decentralized Clinical Trials
FDA
The agency’s newest draft guidance supports the use of DCTs for drugs, biologics, and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites.
May 11, 2023
Regulatory
FDA Requiring Mail-back Envelopes for Opioid Analgesics
FDA
All manufacturers of opioid analgesics used in outpatient settings will be required to submit the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days of the date of the FDA’s notification letter.
April 6, 2023
Regulatory
FDA Issues Guidance for Cybersecurity of Medical Devices RTA Policy
FDA
The document addresses the Consolidated Appropriations Act, 2023, Ensuring Cybersecurity of Medical Devices section’s refuse to accept policy for cyber devices and related systems.
April 2, 2023
Regulatory
FDA Issues Guidances for Medical Device Transition Plans
FDA
The agency has issued the documents to assist with transition plans for COVID-19-related medical devices.
March 28, 2023
Regulatory
FDA Publishes Final Continuous Manufacturing Guidance
FDA
The Continuous Manufacturing of Drug Substances and Drug Products guidance represents proactive steps the FDA is taking to facilitate the pharmaceutical industry’s adoption of advanced manufacturing technologies.
March 7, 2023
Cannabis
FDA Issues Final Guidance on Human Drugs Containing Cannabis
FDA
The agency’s ‘‘Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research’’ document finalizes the draft guidance issued in 2020.
February 1, 2023
Packaging/Filling
Pharmapack Experts Predict Future of European Packaging Companies
Pharmapack Europe
Many smaller and medium-sized European packaging companies will have to grow or face being acquired in 2023, according to Pharmapack Europe experts.
January 26, 2023
Regulatory
FDA Issues Draft Guidance on Breakthrough Devices Program
FDA
The goal of the updates is to reduce existing disparities in health and healthcare in the U.S.
November 14, 2022
Regulatory
FDA Lists Mechanisms to Comply With CGMP Requirements for CPs
U.S. Food and Drug Administration
While the FDA has provided examples of mechanisms, CP manufacturers should consider the suitability of an approach in the context of their product and manufacturing process.
September 19, 2022
Regulatory
FDA Issues Medical Device Production Computer Software Guidance
U.S. Food and Drug Administration
The draft guidance provides recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system.
September 15, 2022
Page 1 of 68
Next Page
