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Medical Devices › Regulatory Agencies

Manatt, Phelps & Phillips, LLP

Laboratory Association Sues FDA Over its Recent Laboratory-Developed Test Final Rule

Manatt, Phelps & Phillips, LLP on

On May 29, the American Clinical Laboratory Association (ACLA) sued the Food and Drug Administration (FDA) in an effort to vacate its recent final rule that will gradually phase out FDA’s long-standing policy of enforcement...more

McDermott Will & Emery

UK Medical Device Regulator Proposes a 12 Month Delay for UKCA Requirements and the New Medical Device Regulations

McDermott Will & Emery on

On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention: - To extend the current standstill period by twelve months from...more

Hogan Lovells

CRO Engagement: A compliance checklist to identify red flags and prevent bribery compliance risks

Hogan Lovells on

The engagement of Clinical Research Organizations (CROs) by pharmaceutical and medical device companies to manage some or all of their clinical trial-related duties and functions is becoming more and more relevant as the...more

Mintz - ML Strategies

What You Need to Know: State and Federal Updates Related to COVID-19

Mintz - ML Strategies on

...On Monday, House Speaker Nancy Pelosi, Majority Whip James Clyburn, Transportation & Infrastructure Committee Chairman Peter DeFazio, and Energy & Commerce Committee Chairman Frank Pallone held a press conference on a...more

McDermott Will & Emery

US Office of Management and Budget Issues a Memorandum Calling for Agency Plans From Federal Government Agencies

McDermott Will & Emery on

On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...more

Hogan Lovells

[Webinar] Health Care and the Internet of Things: New Regulatory Developments - July 25th, 2:00pm EDT

Hogan Lovells on

Please join the Hogan Lovells Communications and FDA practices on Thursday, July 25th for our webinar, Health Care and the Internet of Things: New Regulatory Developments. We will explore new policy initiatives and...more

Hogan Lovells

UK MHRA consults on no-deal Brexit legislation

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more

Hogan Lovells

UK publishes paper on Brexit and medicines regulation

Hogan Lovells on

On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more

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