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337 Results
Type: Article
Section: Industry News > Regulatory
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.
April 28, 2021
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.
April 7, 2021
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
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
Supplier News
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
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
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
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
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
Pharmaceuticals
W.H.O.: Global Emergency Declared as Wuhan Coronavirus Spreads
Most of the 8,000 cases have been reported in mainland China.
January 30, 2020
Regulatory
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.
January 29, 2020
Regulatory
Controversial new labeling idea
Headlines from the U.K. sound promising but reading deeper reveals very little benefit for contemplating such a major change for food manufacturers.
December 28, 2019
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