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Section: Industry News > Regulatory
Supply Chain
HDA Traceability Seminar in D.C. PLUS Webinar Series
Healthcare Distribution Alliance (HDA)
HDA will hold a webinar series (August 11 and 25 and September 15 and 29) prior to the in-person Traceability Seminar taking place October 12 to 14 in Washington D.C. Sessions will cover DSCSA, EPCIS, wholesale distributor services, VRS, and more.
July 22, 2022
Medical Device/Packaging
Fundamentals of Medical Device Packaging: In-Person Course Oct. 2022
The course, developed through IoPP’s Medical Device Packaging Technical Committee, takes place at McCormick Place at PACK EXPO International in Chicago (class dates: Oct 24-26) in three half-day sessions, totaling 13.5 hours.
July 22, 2022
Regulatory
FDA Holding Webinar on Animal Drug Manufacturing System eSubmitter Tool
U.S. Food & Drug Administration
The session will provide information about new enhancements to the system used to support the creation of electronic, secure submissions to the FDA’s Center for Veterinary Medicine for review.
June 20, 2022
Regulatory
FDA Issues Radiation Sterilization Update for PMA Holders
U.S. Food & Drug Administration
The agency is considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation.
June 13, 2022
Regulatory
2022 PDA/FDA Joint Regulatory Conference
Hosted by the Parenteral Drug Association (PDA), the conference takes place Sep 12 - Sep 14, 2022 in Washington D.C.
June 3, 2022
Regulatory
FDA Flexibilities to Yield Millions of Cans of Additional Infant Formula
U.S. Food and Drug Administration
In the coming months, the FDA will be able to greatly increase the supply of formula, including Abbott EleCare, available to U.S. consumers through international and domestic manufacturing facilities.
May 26, 2022
Inspection
FDA Releases White Paper on Quality Management Maturity
The new white paper discusses developing a framework to evaluate the QMM of pharmaceutical manufacturing sites and the benefits of a rating system.
May 23, 2022
Supply Chain
2022 GS1 Connect: Adapt in San Diego, CA
Expand your professional network and gain new insights on supply chain excellence, June 7-9, 2022. Register by June 1.
May 20, 2022
Market Trends
PDA's Glenn E. Wright, To Be Named President & CEO, March 2023; Richard M. Johnson to Retire
Richard M. Johnson concludes an eventful and successful 13-year term at PDA's helm, handing the reins to Glenn E. Wright, PDA COO.
May 19, 2022
Sustainability
Medical Device eIFUs: Hurdles to Overcome
Live from the[PACK]out: Regulations, regional acceptance, and validated packaging configurations all play a role. The challenges aren’t insurmountable but will require efforts from the packaging community.
May 12, 2022
Medical Device/Packaging
KiiP Tackles Wicked Problems in Package Material Stability
What began as a chat over coffee has led to work on a hypothesis and a white paper with far-reaching potential in saving time and resources in medical device packaging stability testing. Efforts were presented at the[PACK]out's inaugural event in Austin.
May 10, 2022
Inspection
FDA Permits Marketing for Test to Improve Diagnosis of Alzheimer’s Disease
U.S. Food & Drug Administration
The Lumipulse test is intended to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations found in human cerebral spinal fluid.
May 6, 2022
Market Trends
Quotables and By the Numbers: May 2022
Quotes and stats in healthcare packaging and logistics, from distribution to sustainability and beyond...
May 3, 2022
Regulatory
the[PACK]out:Â Supply Chain - Navigating Disruptions
EXPERIENCE the[PACK]out: Created for industry professionals, by industry professionals.
April 26, 2022
Regulatory
FDA Issues New Guidance to Increase Racial and Ethnic Diversity in Clinical Trials
U.S. Food & Drug Administration
The agency’s focus on inclusion in trials for all medical products aligns with Biden Administration’s Cancer Moonshot goal of addressing inequities and beyond.
April 22, 2022
Traceability/Serialization
HDA Guidelines for Bar Coding in Pharmaceutical Supply Chain Available
Healthcare Distribution Alliance (HDA)
The document serves as a resource on the use of GS1 system data structures and symbologies to comply with the Drug Supply Chain Security Act’s serialized product and data requirements.
April 18, 2022
Medical Device/Packaging
Cybersecurity in Medical Devices: FDA Announces New Draft Guidance
U.S. Food & Drug Administration
The new guidance deals with quality system considerations and the content of premarket submissions for members of the medical device industry, as well as Food and Drug Administration staff.
April 15, 2022
Temp Control/Cold Chain
10 Temperature Monitor Qualification Considerations
From the 2022 ISTA Forum TempPack: Panelists discussed the latest on temperature recording device (TRD) qualification, including dry ice and LCD screens, probes that disconnect, and what to consider before selecting a shipper integrated with a TRD.
April 15, 2022
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![At the[PACK]out, presenting 'Wicked Stability: Predicting the Aging Degradation of Materials' were speakers (from left): Dan Burgess, Henk Blom, and Rod Patch w/ Moderator Seema Momin.](https://img.healthcarepackaging.com/files/base/pmmi/all/image/2022/05/Wicked_Stability.627af09af0762.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
