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402 Results
Type: Article
Section: Industry News > Regulatory
Robotics/Automation
Serialization Continues to Impact Pharma Automation Investments
Automation and IoT are on trend, as the industry continues to meet serialization regulations.
December 10, 2020
Traceability/Serialization
FDA Dec. Meeting: Drug Supply Chain Security Act Pilot Project Program
FDA
FDA will host a virtual public meeting Dec. 8 and 9, 2020.
November 25, 2020
Adherence/Delivery
COVID-19 Vaccine: HHS Partnering with Major Pharmacy Chains
The partnership will cover approximately 60% of pharmacies throughout the U.S. states, D.C, Puerto Rico, and the U.S. Virgin Islands.
November 16, 2020
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.
October 23, 2020
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.
October 1, 2020
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.
September 15, 2020
Temp Control/Cold Chain
ISTA Pharma Committee Virtual Roundtable Discussions: Aug. 11 and 25
International Safe Transit Association (ISTA)
As a follow up to the open meeting held in June, the ISTA Pharma Committee will host two roundtable discussions in August to discuss in-depth the top two topics of interest from the industry survey.
August 5, 2020
Medical Device/Packaging
Smithers tests med devices
Smithers
Smithers, a leading provider of testing, consulting, information, and compliance services, has announced the formation of the Medical Device Testing division.
July 20, 2020
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.
July 17, 2020
Regulatory
New FDA Insight Podcast on Emerging Topics
First guest: FDA commissioner Dr. Stephen Hahn on fighting COVID-19 at FDA.
June 24, 2020
Traceability/Serialization
3 EPCIS Data Exchange Issues in Pharma Traceability
Conformance testing services have emerged to cut down on wasted back-and-forth between manufacturers and trading partners to get efficient data exchange up and running.
June 16, 2020
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.
June 12, 2020
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.
June 9, 2020
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.
May 14, 2020
Traceability/Serialization
DSCSA and COVID-19
How is the pandemic response impacting the complex and evolving national traceability goals for pharmaceuticals?
May 12, 2020
Supply Chain
HDA: The Need for Distributor-Pharmacy Partnership During Pandemic
Healthcare Distribution Alliance is seeking to provide “a greater understanding of how distributors are working each day” to meet inventory needs for supply chain partners and patients.
April 28, 2020
Regulatory
FDA Authorizes First COVID-19 Test for Patient At-Home Sample Collection
FDA
Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing.
April 28, 2020
Cannabis
Cannabis Relief Bill Introduced in House
“This critical legislation would allow legal cannabis businesses to access disaster relief loans and other programs available during the COVID-19 crisis,” NCIA Executive Director.
April 24, 2020
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