Mask Maker Warned for Unapproved Device
The FDA hit Phoenix, Arizona-based devicemaker CPAPNEA Medical Supply with a warning letter for marketing a device without premarket approval. Source: The GMP Letter
Rhode Island Firm Draws Warning for Design Controls
Rhode Island device manufacturer Unetixs Vascular drew an FDA warning letter for failing to meet design requirements for its MultiLab Series ROODRA vascular diagnostic system. Source: The GMP Letter
No Reported Device Shortages From Coronavirus Outbreak, FDA Says
FDA Commissioner Stephen Hahn said that the agency is not aware of any medical device shortages connected to the outbreak of the novel coronavirus — but the agency is aware…
FDA Allows Early Release of COVID-19 Diagnostics
The FDA issued a new policy that will allow certain laboratories to use validated COVID-19 diagnostics while the agency reviews their Emergency Use Authorization (EUA) requests. Source: The GMP Letter
WHO Considers Unit-Level Serial Numbers for Drug Tracking
The World Health Organization (WHO) is seeking comments by February 28 on a draft policy on tracking and tracing drugs through the supply chain that would push globally for unit-level…
483 Roundup: FDA Cites Seven Firms for GMP, Quality Lapses
The FDA hit drugmakers in China, South Korea, India and Germany for numerous GMP and other violations observed during agency inspections. Source: Drug GMP Report
Warning Letters: FDA Warns Drugmakers in China and Germany
The FDA issued warning letters to drug manufacturing facilities in China and Germany for lax testing, recordkeeping and other failures. Source: Drug GMP Report
Pharma Companies Support Use of Blockchain for Drug Tracking
A blockchain-based drug tracking network is capable of meeting future supply chain regulatory requirements, according to pharma companies that took part in a pilot program run by the FDA. Source:…
Coronavirus Outbreak: Former FDA Commissioner, API Manufacturers Call for Action
Former FDA Commissioner Scott Gottlieb warned of the potential for “unprecedented supply chain disruptions” as the COVID-19 outbreak threatens China’s production of starting materials. The agency reported the first coronavirus-related…
Ireland’s NSAI Becomes 11th Notified Body Under EU MDR
NSAI said it will begin accepting applications for conformity assessment activities from April 1, 2020. Source: Devices & Diagnostics Letter
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