2001 Drugs Packaging Treatment 
Agency IQ
NOVEMBER 3, 2023
Currently, only Article 23a and Article 81 of Directive 2001/83/EC address medicines supply across the E.U. Under the proposal, these elements would be addressed within the revised pharmaceutical regulation, thereby addressing drug shortages at a consistent, E.U.-wide no available alternative treatments, 2. wide level.
Agency IQ
JULY 12, 2024
In response to even more acute drug shortages during the Covid-19 pandemic, the European Commission issued proposals to set up a “European Health Union” meant to address drug shortages in several ways. The non-paper also suggested three potential actions to address drug shortages. Read AgencyIQ’s analysis of the non-paper.]
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Drug Discovery World
AUGUST 24, 2023
In the second part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of psilocybin in drug discovery. Moreover, the US Food and Drug Administration (FDA) granted breakthrough therapy status to psilocybin in 2018 for treatment-resistant depression, and in 2019 for major depressive disorder 4.
Agency IQ
MARCH 29, 2024
Specifically, the NPRM proposed changes to manifest regulations for shipments of hazardous waste that are exported for treatment, storage, and disposal. Additional revisions that would impact permitting, for example, changes to definitions or references, may also be proposed for other RCRA regulatory sections.
Agency IQ
APRIL 12, 2024
Directive 2001/83/EC and Regulation (EC) No 726/2004. Additionally, reform package included revisions of the regulations for pediatric medicines and orphan drugs. For the regulation , this centered on market exclusivity for orphan drugs and whether there should be a separate category for medicinal products addressing unmet need.
Agency IQ
DECEMBER 15, 2023
The allowance or “variance” to the prohibition on the open burning of hazardous waste was established at a time when there were no alternatives to the safe treatment of waste explosives. This routine Methods Update Rule (rMUR) was proposed in February 2023. EPA is not considering methods for new analytes in this routine MUR.
Agency IQ
JUNE 16, 2023
Proposed Rule Stage Restoration of Inadvertently Removed Exemption From the Requirements of FIFRA 2070-AK25 August 2023 In 2001, EPA inadvertently removed an exemption from the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
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