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1,251 Results
Type: News
Section: Industry News > Regulatory
Temp Control/Cold Chain
ANSI/PDA Standard on Cryopreservation of Cells for Cell and Gene Therapies Receives Complete Recognition Status by U.S. FDA CBER
The Parenteral Drug Association (PDA)
The 2021 standard is included in a cohort of standards relevant to regenerative medicine therapies recognized either completely or partially by the Center for Biologics in 2023.
April 4, 2024
Supply Chain
HDA Issues Policy Platform Addressing Drug Shortages
Healthcare Distribution Alliance (HDA)
March 4, 2024
Regulatory
Syntegon Podcast Covers Pharma Topics From a Machine-Builder Point of View
Syntegon
On Syntegon’s new podcast series “Machines & Medicine,” pharmaceutical manufacturing experts discuss complex issues in the industry, which faces regulations like no other.
December 14, 2023
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FDA Issues Draft Guidance for Biosimilar Products Labeling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
Medical Device/Packaging
thePACKout 2024 Call for Abstracts is OPEN
October 6th is the last day to submit abstracts (submission site closes at 11:59 PM EST).
September 27, 2023
Adherence/Delivery
FDA Approves OTC Designation for Vonco’s Enteral Feeding Solution
Vonco Products, LLC
EnteraLoc Flow is the first seamless, closed-loop enteral feeding solution that combines a spill-proof pouch, direct-connect ENFit® device, tube, and nutritious food options in a single, complete feeding system.
September 26, 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
Traceability/Serialization
Antares Vision Group Joins NABP Pulse Interoperable Partner Program
Antares Vision Group
AVG becomes the first DSCSA solution provider to join the program, demonstrating and extending the company’s commitment to DSCSA compliance.
September 7, 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
Traceability/Serialization
HDA Statement on FDA Enforcement Discretion for the DSCSA’s Final Implementation Requirements
“Given the interdependency of the pharmaceutical supply chain, successful implementation of the DSCSA is predicated on all trading partners having systems and procedures tested and ready to go for unit-level serialization," adds HDA's Chip Davis, Jr.
August 25, 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
Supply Chain
Department of Labor Launches Program to Address Workplace Hazards
U.S. Department of Labor
The OSHA national emphasis program is aimed at preventing and reducing workplace hazards in warehouses, distribution centers, and more.
August 1, 2023
Traceability/Serialization
Antares Vision Group Attains ISO/IEC 27001 Certification
Antares Vision Group
Obtained through rfxcel, the information security management systems certification demonstrates the group’s ability to protect and manage customers’ data on a global scale, complementing rfxcel’s ISO 9001 certification.
July 12, 2023
Cannabis
FDA, FTC Warn About Selling Copycat Products Containing Delta-8 THC
FDA
Six companies have been told to stop selling products that use similar brand names, logos, or pictures on packaging to mimic well-known snack food brands.
July 10, 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
RRD (R.R. Donnelley & Sons)
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
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