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1,251 Results
Type: News
Section: Industry News > Regulatory
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Cybersecurity in Medical Devices: FDA Announces New Draft Guidance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
Medical Device/Packaging
FDA Recommends Use of Duodenoscopes With Innovative Designs to Enhance Safety
U.S. Food & Drug Administration
The agency is providing new information supporting the transition to fully disposable duodenoscopes and those with disposable components, as well as new information on completed post-market surveillance studies.
April 8, 2022
Traceability/Serialization
Rx Supply Chain Progressing on EPCIS Adoption for DSCSA, Yet Challenges Remain
Healthcare Distribution Alliance (HDA)
HDA Research Foundation’s latest EPCIS Implementation Benchmarking Survey assesses industry progress of adopting GS1 Electronic Product Code Information Services (EPCIS) and trading partner plans for sending data.
March 21, 2022
Sustainability
Sanofi Recognized for Sustainability Efforts
S&P Global Ratings has named Sanofi one of the world’s most sustainability-committed companies, with a score of 86 out of 100 points, one of the highest scores across all sectors globally.
March 14, 2022
Medical Device/Packaging
Endoscope Processing in Healthcare Facilities Guidance Updated
The guidance explains the required steps in processing flexible and semi-flexible endoscopes and accessories to ensure they are safe for patient use.
March 8, 2022
Supply Chain
Thermo Fisher Scientific Offers New Integrated Packaging, Distribution Services
Thermo Fisher Scientific
The end-to-end solution combines cryogenic and cold chain logistics, serialization compliance, and global distribution for cell and gene therapy innovators.
March 4, 2022
Logistics
FDA Issues Voluntary Recalls Final Guidance
The guidance will help companies prepare to quickly and effectively remove violative products from the market, as the agency urges companies to be “recall ready” to protect public health.
March 4, 2022
Regulatory
Industry Reacts to FDA Draft Guidance on Injectable Products Inspection
Pharmaceutical companies and the International Society for Pharmaceutical Engineering want the FDA to align visible particle classifications and inspections with USP.
March 1, 2022
Regulatory
FDA Proposes Rule to Amend Medical Device CGMP Requirements
The proposed amendments to the CGMP requirements of the Quality System (QS) Regulation will align them more closely with the international consensus standard for devices.
February 28, 2022
Sustainability
Ceres: Major U.S. Companies Call for Swift Passage of Ambitious Federal Climate Policy to Build an Affordable, Competitive Clean Economy
This follows a December letter signed by over 400 investors and companies—including Bayer, Danone, and DS Smith—sent to members of Congress calling for the “swift enactment” of the historic climate investments.
February 16, 2022
Regulatory
New FDA Chief Confirmed by Senate
Dr. Robert Califf narrowly secures position again on a 50-46 vote, despite concerns over his pharmaceutical industry ties.
February 16, 2022
Regulatory
GAO Makes Recommendations to Improve FDA Foreign Inspection Program
Drugs manufactured overseas for the U.S. market must meet the same requirements as those manufactured in the U.S., raising questions about the equivalence of foreign to domestic inspections.
February 9, 2022
Regulatory
FDA Proposes Rule for Wholesale Drug Distributors, Third-party Logistics Providers
If passed, the rule would allow only those licensed according to the proposed national standards to engage in transactions related to the sale and distribution of certain prescription drugs with other members of the supply chain.
February 8, 2022
Regulatory
FDA Publishes Draft Guidance on Reporting Certain Medical Device Shortages
The new guidance helps clarify how the agency interprets 506J notification requirements, including when and who should submit a notification and the information that should be included.
February 1, 2022
Regulatory
FDA Releases Medical Devices Draft Guidance for Review
“The Transition Plan for Medical Devices Issued Emergency Use Authorizations During the Coronavirus Disease 2019 Public Health Emergency” guidance is now available for review.
January 12, 2022
Medical Device/Packaging
MedAccred Grants Volex Accreditation for Cable and Wire Harness Assembly
MedAccred
Volex is the first company in Mexico to hold the prestigious accreditation for this critical manufacturing process.
January 11, 2022
Supply Chain
2021 HDA Traceability Online Seminar Takes Place Nov. 1-3
Healthcare Distribution Alliance (HDA)
Are you prepared to comply with the DSCSA by 2023? Supply chain stakeholders will convene to discuss the most pressing DSCSA-related topics with experts, including a presentation from FDA.
October 7, 2021
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