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Biotechnology › Regulatory Oversight › Medical Devices

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

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Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

Dechert LLP

UK Life Sciences and Healthcare Newsletter- December 2020: Regulatory Updates

Dechert LLP on

Medicines and Medical Devices Bill (MMDB) – The MMDB is intended to act as the primary UK legislation specifying powers that would enable the regulatory regimes for human medicines, clinical trials, veterinary medicines and...more

McDermott Will & Emery

Digital Health in the United Kingdom: The New Regulatory Environment Under the Medical Device Regulation

McDermott Will & Emery on

The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more

Hogan Lovells

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

Hogan Lovells on

On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation...more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market” of products including medical devices

Hogan Lovells on

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

Hogan Lovells

Effects of Brexit on reimbursement decisions concerning medicinal products in Poland

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The President of the Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL) estimates that approximately 20% of all the 10,000 medicinal products registered in Poland will be affected...more

Hogan Lovells

HMA-EMA’s work programme on availability of authorised medicines for human and veterinary use includes measures for Brexit

Hogan Lovells on

On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their...more

Hogan Lovells

UK Parliamentary Committee Publishes Life Sciences Brexit Negotiation Recommendations

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The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. ...more

Hogan Lovells

Clinical trials: Digital technology for recruitment, consent, and data capture

Hogan Lovells on

The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more

Hogan Lovells

UK Government Announces Life Sciences Sector Deal

Hogan Lovells on

The UK government has published a White Paper setting out its new Industrial Strategy and, as part of that strategy, has agreed a Sector Deal with the UK life sciences sector. ...more

Hogan Lovells

The commission assessment – a decision-making aid for EMA's relocation?

Hogan Lovells on

Last week, a staff retention survey was published, according to which certain contestants in the race for hosting the EMA were less liked by the EMA staff. And now the decision-making progress is going forward....more

Hogan Lovells

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

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On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

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