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1,251 Results
Type: News
Section: Industry News > Regulatory
Traceability/Serialization
HDA Statement on FDA Proposed National Standards for Licensure of Distributors and 3PLs
Healthcare Distribution Alliance (HDA)
“...with the deadline to comply with DSCSA’s final phase almost one year away, time is of the essence. That is why HDA urges FDA to align certain sections of the rule as closely as possible so distributors and 3PLs can comply with parallel provisions.”
September 8, 2022
Labeling/Printing
Octapharma Employs Schreiner MediPharm Automated Vial Labeling System
Schreiner MediPharm
The Schreiner MediPharm automatic application solution is ideal even for very small quantities.
August 22, 2022
Packaging/Filling
2022 PDA Pre-Filled Syringes Conference and Parenteral Packaging Courses
Held in Palm Springs, CA, the in-person conference takes place Oct.18 - 19 and the courses follow on Oct. 20.
August 22, 2022
Sustainability
FDA Continues Support of Innovation in Medical Device Sterilization
U.S. Food and Drug Administration
A recent statement details the FDA’s efforts to find ways to reduce EtO emissions and concentrations used to sterilize devices without compromising safety and effectiveness.
August 16, 2022
Regulatory
FDA Finalizes Instructions for Use Guidance
U.S. Food and Drug Administration
The document clarifies IFU labeling for pharmaceutical manufacturers to help consumers understand complicated instructions when using a drug or biologic.
August 2, 2022
Regulatory
FDA Releases Draft Guidance on Use of Remote Regulatory Assessments
The guidance covers voluntary and statutorily authorized RRAs, but does not change the core requirements of inspections and pre- and post-market authorities.
July 26, 2022
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
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
Regulatory
the[PACK]out: 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
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