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Notice of Compliance Data Protection

Smart & Biggar

Federal Court of Appeal restores Minister of Health’s decision to grant RUZURGI NOC despite FIRDAPSE data protection

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As previously reported, the Federal Court quashed a second decision by the Minister of Health (Minister) to issue a Notice of Compliance (NOC) to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, following the...more

Sheppard Mullin Richter & Hampton LLP

What Should We Do About the Draft CPRA Regulations?: Collection and Notice

The California Privacy Protection Agency (CPPA) recently released the draft proposed CCPA Regulations and draft initial statement of reasons. Importantly, these are draft regulations that are likely to be subject to extensive...more

Smart & Biggar

Federal Court sets aside decision by the Minister of Health to issue RUZURGI NOC for the second time

Smart & Biggar on

On March 10, 2022, for the second time, the Federal Court set aside a decision by the Minister of Health (Minister) to issue Médunik Canada (Médunik) a Notice of Compliance (NOC) for its amifampridine product, RUZURGI,...more

Smart & Biggar

Federal Court quashes RUZURGI NOC and returns matter to the Minister of Health for redetermination

Smart & Biggar on

Update: On redetermination, Health Canada issued a new notice of compliance for RUZURGI on June 24, 2021. Catalyst and Kye have sought judicial review (Court File No T-1047-21). On May 31, 2021, the Federal Court quashed a...more

Smart & Biggar

Federal Court denies stay of decision issuing NOC for RUZURGI

Smart & Biggar on

On September 30, 2020, the Federal Court dismissed an application by Catalyst Pharmaceuticals Inc (Catalyst) and KYE Pharmaceuticals Inc (KYE) (collectively, the applicants) for an interlocutory injunction to stay the...more

Smart & Biggar

Certificate of Supplementary Protection Regime: First Anniversary Update

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September 21, 2018 marked the first anniversary of the certificate of supplementary protection (CSP) regime. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the...more

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