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1,766 Results
Section: Industry News > Regulatory
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FDA Issues Pediatric Drug Development Draft Guidance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The new draft guidance assists industry members in obtaining the data and information necessary to support the approval of drug products in pediatric populations.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
Temp Control/Cold Chain
Merck Expert Shares 5 Tips for Qualifying Pallet-Sized Thermal Shippers
Find out why Lee Menszak advocates for shipper-to-shipper variability testing from his talk at ISTA’s TempPack event.
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The agency’s newest draft guidance supports the use of DCTs for drugs, biologics, and devices, where some or all the trial-related activities occur at locations other than traditional clinical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
Rare Disease Patient and Advocate Talk Actions You Can Take
“We don't believe patients should have to start their own drug company to save themselves or save their child,” says Julia Jenkins, policy expert, at the PDA Annual Meeting.
April 3, 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
Regulatory
Rx 360 - The International Pharmaceutical Supply Chain Consortium
February 27, 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
Medical Device/Packaging
Roundtable Ahead of Pharmapack Europe Talks Drug Delivery Trends
From patient-centricity in a connected world to holistic sustainability strategies and proposed MDR amendments, hear what consultants have to say about the changing medical device landscape in 2023.
January 20, 2023
Regulatory
Counting Down the Top 10 Articles of 2022 - #1: Pitfalls to Avoid in FDA Aseptic Manufacturing Inspections
Join us as we look back at the most-read Healthcare Packaging stories of 2022. At #1, from personnel to facility design to process, FDA policy advisor provides an outline of what facilities can improve on.
January 4, 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’s Proposed Change to NDC: Comments Due Nov. 22, 2022
The NDC proposal is intended to minimize the impact of “running out of ten-digit national drug codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs.”
November 1, 2022
Traceability/Serialization
How Missing Traceability Data Might Affect Pharmacy Patients
If accurate and complete pharma traceability data isn't supplied to pharmacists, they may end up scrambling to serve the patients in front of them. Pharmacy leaders discuss how this may affect relationships with nonconforming trading partners.
October 14, 2022
Traceability/Serialization
DSCSA: Labels Practically as Important as the Medicine Itself
In becoming compliant with interoperable data exchange requirements under DSCSA, don’t overlook the pharmaceutical label itself. Missing case labels or faded inks can pose threats.
October 4, 2022
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