Regulatory Affairs
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Mifepristone Access Continues Under Supreme Court Hold as Planned Parenthood Responds to 5th Circuit Ruling
Planned Parenthood can continue dispensing Mifepristone by mail and certified pharmacies until May 11 following Supreme Court provisional hold on 5th Circuit ruling.
TGA Issues Guidance on Combination and Boundary Products for Pharmaceutical Companies in APAC
Australia's TGA provides regulatory clarity on combination products like pre-filled syringes and boundary products including nasal decongestants.
Aquestive Therapeutics Faces Class Action Lawsuit Over Anaphylm Drug Approval Timeline Claims
Investors file class action against Aquestive Therapeutics alleging misleading statements about Anaphylm sublingual film approval timeline and January 2026 PDUFA date.
Australia's TGA Updates Comprehensive Biologicals Regulatory Framework for Advanced Therapies
Australia's TGA provides updated guidance on biologicals regulation including blood products, tissues, and advanced therapies under ARGB framework.
Australia's TGA Updates Therapeutic Sunscreen Regulatory Framework for Enhanced Consumer Protection
Australia's TGA provides comprehensive guidance on therapeutic sunscreen regulation, covering application processes, market authorization, and compliance requirements.
Australia's TGA Updates Medicinal Cannabis Access Guidelines for Pediatric Patients Under Special Access Scheme
Australia's TGA clarifies medicinal cannabis access requirements for pediatric patients under 18 through Special Access Scheme and Authorised Prescriber pathways.
Australia's TGA Updates Guidance for Accessing Unapproved Therapeutic Goods Through Special Access Scheme
Australia's TGA provides updated pathways for healthcare practitioners and consumers to access unapproved therapeutic goods not on the ARTG register.
Australia's TGA Updates Over-the-Counter Medicine Registration Guidelines for Pharmaceutical Companies
Australia's Therapeutic Goods Administration releases updated guidance on over-the-counter medicine registration requirements for pharmaceutical manufacturers.
Australia's TGA Expands Therapeutic Vaping Access Through Pharmacy Channels with New Regulatory Framework
Australia's TGA establishes new pathways for therapeutic vaping products through pharmacies, expanding access to regulated e-cigarettes as therapeutic goods.
Australia's TGA Updates Assessed Listed Medicines Framework for Enhanced Pre-Market Evaluation
Australia's TGA enhances assessed listed medicines regulations, allowing intermediate health claims with pre-market efficacy evaluation for low-risk ingredients.
Corcept Therapeutics Faces FDA Rejection of Relacorilant for Cushing's Syndrome, Investor Lawsuit Filed
Corcept Therapeutics received FDA Complete Response Letter rejecting relacorilant for Cushing's syndrome due to insufficient evidence, sparking investor lawsuit.