California Designated Representative Training Course for 3PL (approved by the California State Board of Pharmacy) “The impact of new 3PL licensing The big license aftershock following the DSCSA earthquake came when the FDA redefined the parameters of 3PL companies. Before the passage of DSCSA, 3PL companies could be licensed as a wholesaler. Now, that’s no longer the case.” […]
Tag: FDA
FDA Steps in to Regulate Microneedling Devices | RAPS
“The US Food and Drug Administration (FDA) on Thursday issued a draft guidance detailing when it considers “microneedling” products to be medical devices and subject to regulation.” Read the full article – Source: FDA Steps in to Regulate Microneedling Devices | RAPS Read the guidance: Regulatory Considerations for Microneedling Devices – FDA (PDF) Go to DREprof.com: The […]
FDA Clarifies DSCSA Entities And Trading Partners
Entities & Trading Partners Defined Under The DSCSA “The Food and Drug Administration (FDA or the Agency) is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). DSCSA establishes product tracing […]
GS1 US Workshop Series Offers Pharmaceutical Industry Professionals DSCSA Implementation Assistance | Healthcare Packaging
“Specifically, how to mark pharmaceutical products with a National Drug Code (NDC), serial number, lot number, and expiration date in both machine-readable and human-readable format will be covered, as will the use of GS1 identifiers, application identifiers, and data carriers.” Read the full article (Source): GS1 US Workshop Series Offers Pharmaceutical Industry Professionals DSCSA Implementation […]
Refurbished Medical Devices: FDA Wants to Hear More From Industry | RAPS
“The US Food and Drug Administration (FDA) on Thursday announced that it’s seeking more information on medical devices that are refurbished, reconditioned, rebuilt, remarketed, remanufactured, serviced or repaired in order to investigate a number of potential safety issues.” Read the full article: Source: Refurbished Medical Devices: FDA Wants to Hear More From Industry | RAPS […]
New Draft Guidance Clarifies UDI Exceptions for Convenience Kits – FDA Law Blog
“On January 4, CDRH issued its first draft device guidance of the year. The Draft Guidance “Unique Device Identification: Convenience Kits” explains FDA’s position as to what constitutes a convenience kit for purposes of the UDI Rule.” Read the full article: Source: FDA Law Blog: New Draft Guidance Clarifies UDI Exceptions for Convenience Kits Go […]