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1,251 Results
Type: News
Section: Industry News > Regulatory
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The agency’s newest draft guidance supports the use of DCTs for drugs, biologics, and devices, where some or all the trial-related activities occur at locations other than traditional clinical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
Traceability/Serialization
Antares Vision Group Partnering With Renown Health Network
Antares Vision Group
rfxcel, part of Antares Vision Group, will implement DSCSA compliance solutions to help ensure pharmacies across the northern Nevada healthcare network comply with the regulations.
March 16, 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
Industry News
Working Group Formed to Improve Medical Device Quality, Supply Chain
MedAccred
The new working group was inspired by the FDA Center for Devices and Radiological Health’s Case for Quality Initiative, which seeks to collaboratively advance the quality, safety, and effectiveness of medical devices.
February 16, 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‘‘Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research’’ document finalizes the draft guidance issued in 2020.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
Labeling/Printing
Schreiner MediPharm to Showcase First-Opening Indication Feature
Schreiner MediPharm
The novel combination of needlestick and product protection for the company’s protective Needle-Trap solution will debut at Pharmapack Paris.
January 12, 2023
Materials
Pharmapack Europe 2024 to Have 2 New Dedicated Zones
Pharmapack Europe
The event will have the new zones in 2024 due to the growth of biologics, new modalities, and contract packaging.
January 10, 2023
Supply Chain
HDA Issues Statement on PREVENT Pandemics Act
Healthcare Distribution Alliance (HDA)
The bipartisan legislation included in omnibus bill would bolster supply chain resilience capabilities.
December 26, 2022
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
Packaging/Filling
Aphena Pharma Solutions Completes 3-Year, $20M Tennessee Expansion
Aphena Pharma Solutions, LLC
The expansion will allow the company to grow its bottle and blister packaging capacity, making Aphena a strong strategic growth partner for generic and OTC pharmaceutical companies.
November 9, 2022
Traceability/Serialization
Graphic Packaging Introducing Advanced Pack Serialization Solution
Graphic Packaging International
The new product will help pharma companies clamp down on counterfeit healthcare products and improve patient safety.
November 2, 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
Packaging/Filling
NIST Providing $3M for Biopharma Manufacturing Equipment Advancements
The funding for new equipment will support the advancement of biopharmaceutical manufacturing processes and provide expanded opportunities for workforce development.
September 14, 2022
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