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Analysis Life Sciences Thank You Ahead of a November deadline, FDA finalizes guidance on waivers, exemptions or exceptions from supply chain security requirements

Agency IQ

a wholesaler or pharmacy) would be able to see a valid chain of custody for a product. They may seek “exceptions… to the requirements relating to product identifiers if a product is packaged in a container too small or otherwise unable to accommodate a label.” The system is intended to increase transparency and safety.

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Analysis Life Sciences Thank You Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement

Agency IQ

The questions contained in the letter are organized into six high-level topics : (1) current market dynamics; (2) (regulatory) pathway; (3) federal-state interaction; (4) safety; (5) quality; and (6) form, packaging, accessibility, and labeling. Alternatively, Congress could simply grant a specific preclusion for CBD.

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Analysis Life Sciences Thank You After 13-year review, FDA finalizes ‘clear, conspicuous and neutral’ drug advertising rule

Agency IQ

Many posted comments came from professional pharmacy organizations, trade groups like the Pharmaceutical Research and Manufacturers of America (PhRMA) , and pharmaceutical companies, such a Eli Lilly , Novo Nordisk and Merck.

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Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

Agency IQ

In October 2024, the European Commission published a communication putting forth a package of reforms to address medicines shortages. active pharmaceutical ingredient, fill/finish, packaging/labeling). Read AgencyIQ’s analysis of the non-paper.] points of disruption).

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Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

This report also refers to an article in the Wall Street Journal indicating that, between 1993 and 1998, the government spent $3.9 In some cases, manufacturers have determined that specific drug products have limited stability when the original packaging is opened. million on stability testing for the SLEP program, resulting in $263.4

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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

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