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Stikeman Elliott LLP

The Pharmacare Act Receives Royal Assent

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On October 10, 2024, Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received Royal Assent. This legislation establishes a framework for a national universal pharmacare system, aiming to enhance the...more

Faegre Drinker Biddle & Reath LLP

The UK Cyber Security and Resilience Bill

The UK government has recently announced that it plans to introduce a Cyber Security and Resilience Bill (Bill). The Bill seeks to update the 2018 Network and Information Security Regulations, which implemented the European...more

Stikeman Elliott LLP

Regulatory Amendments Impacting Drug and Medical Device Recalls Coming Into Force

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On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

Knobbe Martens

New Ethylene Oxide Regulations may Raise Cost of Sterilization

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Last week, the Environmental Protection Agency (EPA) announced new regulations to reduce ethylene oxide emissions. According to the EPA’s press release, the new regulations are “the strongest measures in U.S. history to...more

Hogan Lovells

Medical device advertising in Spain

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The Ministry of Health takes steps to update the regulatory framework applicable to the advertising of medical devices. The Spanish Health Act gives the authorities control over health advertising. In particular, Article 102...more

American Conference Institute (ACI)

Tips for Entering the Life Sciences Market in Brazil

For life sciences companies, Brazil’s market offers both an abundance of business opportunities and a myriad of on-the-ground regulatory compliance challenges for new entrants. Getting the market-entry strategy right will...more

Quarles & Brady LLP

Ohio Board of Pharmacy Formalizes a Pathway for Approval of Innovative Pharmacy Arrangements

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Effective March 11, 2022, Ohio Board of Pharmacy (“Board”) enacted a new regulation, Ohio Admin. Code 4729:5-3-20, that creates a procedure for licensees to petition the Board for approval of pilot or research projects...more

Latham & Watkins LLP

UK’s MHRA Seeks “Bold New Regulatory Regime” for Medical Devices and Diagnostics

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The agency’s consultation on the post-Brexit regulatory framework for medical devices and diagnostics aims to support innovation and sustainability, among other goals. A 10-week consultation launched by the UK’s Medicines...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - June 2021

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Biden Releases Federal Budget Proposal for 2022: On May 28, 2021, President Biden released the proposed budget for fiscal year 2022, which would increase health spending by 23%. The proposal urges Congress to enact drug...more

Smart & Biggar

Special Access Program and Emergency Drug Release Program amendments in force

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On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more

Hogan Lovells

New medical device regulation in Spain opened for public consultation

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Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

McDermott Will & Emery

The EU Medical Device Regulation: What’s Next?

The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more

McDermott Will & Emery

European SPC Manufacturing Waiver Goes into Force

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Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

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