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Catalyst Pharmaceuticals, Inc.

https://catalystpharma.com/

Latest From Catalyst Pharmaceuticals, Inc.

Regulators Keep Rare Diseases Open For Business

The cost of rare diseases to patients and society at large is 10 times higher than for many of the biggest mass market diseases combined. With 95% of rare diseases lacking a treatment or cure, there is an economic imperative for policymakers to keep encouraging pharmaceutical companies to develop more orphan drug treatments. In Vivo looks at the US and EU regulatory impetus to keep rare diseases open for innovation. 

Rare Diseases FDA

Patient Data In Drug Reviews Would Be Encouraged In Proposed Amendment To User Fee Bill

Rep. Matsui withdrew amendment on FDA’s use of patient experience data during health subcommittee markup of user fee reauthorization legislation, but it may be considered in full committee markup following agency input. Chair Eshoo says the provision specifying contrast agents must be regulated as drugs needs to be reworked to include ophthalmic products.

FDA User Fees

Orphan Exclusivity, Drug-Device Designation Court Rulings Against FDA Would Be Fixed In User Fee Bill

Draft legislation would undo the Catalyst decision prohibiting FDA from providing separate orphan exclusivity periods for different subpopulations and alter the Genus ruling by requiring FDA to treat contrast agents, radioactive drugs and OTC monograph drugs as drugs.

Rare Diseases Legislation

US FDA Orphan Exclusivity Would Revert To Pre-Catalyst Status Under Senate Legislation

Federal court decision said the FDA cannot grant orphan exclusivity for subpopulations of a disease, which agency officials fear could damage pediatric rare disease drug development.

Rare Diseases Legislation
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    • Catalyst Pharmaceutical Partners Inc.
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