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Take Five
Safety in Aseptic Filling
FDA provides insight into common pitfalls found during inspections along with possible solutions.
Regulatory
FDA Releases Medical Devices Draft Guidance for Review
Regulatory
Pitfalls to Avoid in FDA Aseptic Manufacturing Inspections
Traceability/Serialization
Counting Down the Top 10 Articles of 2021 - #1: Serialization 101
Automation/Robotics
Counting Down the Top 10 Articles of 2021 - #4: Data and AI Accelerate Digital Transformation
Traceability/Serialization
FDA Discusses Nov. 2023 DSCSA Future State
At the HDA Traceability Online Seminar (Nov. 1-3, 2021), FDA’s Connie Jung, RPh, talked about how DSCSA continues to transform the pharmaceutical supply chain to preserve drug safety and security.
Traceability/Serialization
Will Labor Requirements Increase in Meeting DSCSA Milestones?
With many companies either facing or concerned about labor shortages in manufacturing, an expert from Cardinal Health notes that outbound scanning alone may require a 12 to 15% increase in headcount in their operations.
Regulatory
Applying Modern Technology to Pharmaceutical Production Facilities
Robotics, biometrics, and isolator technology are proving cleaner, faster, and safer than traditional manual methods.
Sustainability
EU Regulators, Recycling, and Healthcare Plastics
Packaging suppliers speak about the openness of regulators to understand the slower nature of life science manufacturers in adopting more sustainable packaging.
Traceability/Serialization
HDA Foundation Survey Reveals Uneven Progress on Rx Product Serialization
With 2023 DSCSA requirements around the corner, findings reveal aggregation has slowed. Now in its sixth year, this survey, released as part of HDA’s Traceability Online Seminar (November 1–3), assesses industry abilities to meet DSCSA requirements.
Regulatory
Four DSCSA Guidances Were Released this Summer: Are You Up to Date?
Read what’s new on DSCSA regarding suspect and illegitimate product, product identifiers, and enhanced drug distribution security at the package level.
Regulatory
Fresenius Kabi Goes Above and Beyond DSCSA Requirements
With the support and standards of GS1 US, the pharmaceutical manufacturer fulfills customer needs for an additional system to ensure safe use of medication on a unit-of-use level.
Regulatory
FDA Final Guidance: Form and Content of the Unique Device Identifier (UDI)
The document is intended to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling requirements, including by clarifying FDA’s interpretation of certain requirements under 21 CFR 801.40.
Regulatory
Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages
Guidance for industry and FDA staff. Comments can be submitted.
Cannabis
One Step Closer to Cannabis Access for Medical Research
After years of dragging their heels on approving marijuana cultivation applications for research, the DEA looks to be moving forward with licenses soon.
Take Five
Expedite Med Device Approval with FDA’s New Program
Medical device manufacturers can potentially speed review by testing to recognized standards performed at a list of FDA-accredited labs released in April 2021. Watch this Take Five video to learn more.
Packaging/Filling
2021 PDA Annual Meeting: Trend Roundup
The Parenteral Drug Association (PDA) virtual conference offered plenty of new perspectives in aseptic filling, flexible facilities, and more.
Regulatory
Demystifying FDA’s ASCA on Biocompatibility for Expedited Review
Live from MD&M BIOMEDigital: Medical device manufacturers can potentially speed review by testing to recognized standards performed at accredited labs.
Take Five
5 Tips To Improve Your Remote/Hybrid Audits
Whether you’re a manufacturer or contract organization, audits are a key part of ensuring quality. Don’t overlook these tips from our 'Take Five with HCP' video when switching from in-person supplier audits to virtual or hybrid audits in the pandemic.
Regulatory
PDA to Collaborate with Deloitte and U.S. FDA to Improve the Quality of Compounded Drugs
Courses to cover many PDA areas of expertise, including aseptic processing.
Regulatory
PDA Post-Approval Change Issues and Impacts Survey
This comprehensive survey includes data on the challenges presented by inconsistencies in how regulators treat post-approval changes and respondents’ experience with specific regulators.
Automation/Robotics
Serialization Continues to Impact Pharma Automation Investments
Automation and IoT are on trend, as the industry continues to meet serialization regulations.
Logistics/supply chain
Saleable Returns Verification Delayed to 2023
Additional three-year delay: FDA guidance says distributors will not be required to verify the product identifier of returned drugs before resale until Nov. 27, 2023.
Cannabis
Cannabis Policy Vote May Happen by End of 2020
The MORE Act would be historic in that it would remove cannabis from the Controlled Substances Act, opening a path for regulations to follow.
Regulatory
Live from PDA/FDA: FDA Considers Incentivizing Quality Management Maturity (QMM)
The Agency is soliciting feedback from manufacturers on assessing and rewarding QMM through Oct. 2020. Reduced audit frequency may one day be an incentive for high performers.
Pharmaceutical
CPhI Festival of Pharma 2020 in October
Former FDA commissioner Dr. Scott Gottlieb to address industry on sustainable innovation at the two-week long event. Sessions will cover affordable medicines, supply change resiliency, AI, Vaccine production, and more.
Supplier News
Smithers tests med devices
Smithers, a leading provider of testing, consulting, information, and compliance services, has announced the formation of the Medical Device Testing division.
