Agency IQ

NOVEMBER 3, 2023

Currently, only Article 23a and Article 81 of Directive 2001/83/EC address medicines supply across the E.U. no available alternative treatments, 2. Changes that could be implemented rapidly include using different sources of raw materials and/or finished product, packaging, or changes to batch sizes, manufacturing sites, and equipment.

Regulations 40

Regulations International Pharmaceuticals Production 40

Drug Discovery World

AUGUST 24, 2023

This looks to be a significant milestone which will ideally propel other regulatory agencies forward in this field. For instance, though psilocybin remains illegal in Maryland, The Johns Hopkins Center for Psychedelic and Consciousness Research continues to explore innovative treatments using psilocybin and its potential for mental illnesses 3.

Clinical Trials 130

Clinical Trials Treatment Regulations Trials 130

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.

Regulations 40

Regulations Compliance Production Government 40

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. Generally, all MEPs supported the package in its current form, with political affiliations shaping the provisions each highlighted. citizens; 2.

Pharmaceuticals 40

Pharmaceuticals Packaging Regulations Production 40

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.

Regulations 40

Regulations Compliance Production Government 40

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).

Regulations 40

Regulations Compliance Production Science 40

Drug & Device Law

JULY 31, 2023

2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). 2001) (applying Illinois law); Serpico v. Smith rejected plaintiff’s analogy between books and drug package inserts. May 13, 2015) (contract involving multiple, identical “software package[s]” governed by UCC).

Production 52

Production International Trials Government 52