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1,882 Results
Section: Industry News > Regulatory
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
Aseptic/Sterile
Aptar Requests U.S. FDA Emergency Use Authorization for N95 Filtering Facepiece Respirator Decontamination with ActivShield(TM)
Aptar
The company is working to provide approximately four million ActivShield strips per week and is working to expand its production capacity with the intent to deliver ten million per week by the end of April.
April 17, 2020
Machinery
Take PDA's COVID-19 Survey in Pharmaceuticals
PDA
The Parenteral Drug Association (PDA) is conducting an important assessment to understand industry impacts on operations and supply chains.
April 6, 2020
Logistics & cold chain packaging
PPE and Device Manufacturers: FDA Offers Import Instructions
To increase U.S. supplies, FDA is providing instructions and a specific email address to get questions and concerns addressed quickly.
March 24, 2020
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.
February 10, 2020
Materials
Aptar CSP Technologies: Moisture Adsorption and Oxygen Scavenging Packaging System
Aptar Pharma
Oxygen scavenging and moisture adsorption system added to Aptar CSP Technologies’ 3-phase Activ-Polymer platform technology portfolio.
February 7, 2020
Regulatory
FDA: Draft Guidance Q&A on Promotional Labeling and Advertising for Reference or Biosimilar Products
Comment on the draft by Apr. 6, 2020 before work begins on the final guidance.
February 5, 2020
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