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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
Supplier Submitted
FDA Final Guidance: Form and Content of the Unique Device Identifier (UDI)
Supplier Submitted
Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages
Cannabis
One Step Closer to Cannabis Access for Medical Research
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.
Sponsored
Healthcare Packaging's Life Science Logistics Playbook
Shipping temperature-controlled products? Get tips on preventing excursions and waste, developing a validation master plan, characterizing shipping lanes, and more.
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.
Sponsored
Healthcare Packaging's Life Science Logistics Playbook
Shipping temperature-controlled products? Get tips on preventing excursions and waste, developing a validation master plan, characterizing shipping lanes, and more.
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.
Regulatory
Med Devices and the FDA: Extended Deadline, Worker Safety
In extending UDI compliance dates for low-risk products, FDA cited challenges related to COVID-19. CDRH also issued recommendations for personnel safety in med device manufacturing.
Regulatory
New FDA Insight Podcast on Emerging Topics
First guest: FDA commissioner Dr. Stephen Hahn on fighting COVID-19 at FDA.
Regulatory
Quick Hits: Allergan is Seeking Women with Recalled Breast Implants
Allergan recalled breast implants more than 10 months ago; now they are trying to find the women who still have them.
Regulatory
Quick Hits: FDA Gives Emergency Approval to Fitbit’s Ventilator
The wearable tech company developed a new ventilator to help treat the current health crisis.
Logistics/supply chain
States Focus Legislation on Prescription Drug Costs
Though attention has turned to COVID-19, state legislatures were already pivoting away from last year’s opioid legislation to address drug prices—an issue that requires the Healthcare Distribution Alliance to engage across all 50 states.
Machinery & materials
Take PDA's COVID-19 Survey in Pharmaceuticals
The Parenteral Drug Association (PDA) is conducting an important assessment to understand industry impacts on operations and supply chains.
Regulatory
Honeywell Collaborates With AI Specialist Bigfinite to Speed Medical Therapies
The collaboration will focus on helping biotech and pharma industries understand and make use of artificial intelligence and machine learning to enable faster development.
Pharmaceutical
W.H.O.: Global Emergency Declared as Wuhan Coronavirus Spreads
Most of the 8,000 cases have been reported in mainland China.
Home
Feds Say Not Legal, But Still It’s Not Rare: Why’s CBD for Sale Everywhere?
In our column’s continuing effort to correct common misconceptions about packaging law, this month we turn to cannabidiol, or CBD.
Home
Cannabis Packaging: Don't Fear the Reefer
UnPACKed with PMMI Podcast breaks down the latest developments in cannabis packaging as more and more states open the door to legalization.
