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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Hogan Lovells ordered by Published Date Descending.
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1
Guidances Galore: FDA Finalizes Multiple Digital Health Guidance Documents
On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released a series of guidance documents addressing the agency's ...
United States
14 Oct 2019
2
Clarifying Clinical Decision Support: FDA Overhauls Guidance To Focus On Risk
On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), ...
United States
11 Oct 2019
3
FDA Issues Draft Guidance On Providing Regulatory Submissions In Electronic Format
On 26 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published a draft guidance document entitled "Providing Regulatory Submissions for Medical Devices
United States
4 Oct 2019
4
FDA Announces New Expedited Program For Devices Expected To Significantly Improve The Safety Of Existing Technologies
On 19 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance document entitled "Safer Technologies Program for Medical Devices"
United States
30 Sep 2019
5
FDA Releases Four Final Guidances On The 510(k) Program; Special 510(k) Guidance Confirms New Approach To Eligibility And Broader Potential For IVDs
On 13 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published four final guidance documents on the 510(k) program:
United States
24 Sep 2019
6
Final Guidance Provides Additional Clarity To The Humanitarian Device Exemption Program
On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program."
United States
12 Sep 2019
7
De Novo Requests: FDA Releases Updated RTA Checklist
On 9 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Acceptance Review for De Novo Classification Requests.
United States
11 Sep 2019
8
Uncertainty Remains: FDA Releases New Benefit-Risk Decision Tree For Medical Device PMAs And De Novos In Concert With Final Uncertainty Guidance
On 30 August 2019 the U.S. Food and Drug Administration issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals.
United States
9 Sep 2019
9
A Bit More Sunshine: CMS Proposes Collecting Additional Information On Manufacturer Payments Under The Open Payments Program
Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS)
United States
20 Aug 2019
10
Proposed Additions Of Chemical Families To Schedule 1 Of Chemical Weapons Convention And BIS Requests For Comments From Chemical, Biotechnology And Pharmaceutical Companies
On 14 August 2019 the U.S. Department of Commerce published a proposed change to the list of "Schedule 1" chemicals in the "Annex on Chemicals" to the Chemical Weapons Convention (CWC).
United States
20 Aug 2019
11
New Draft Guidance On MR Compatibility For Medical Devices
The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
United States
15 Aug 2019
12
FDA Details Recommendations For Live Case Presentations During Medical Device Clinical Trials In Final Guidance
This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials
United States
31 Jul 2019
13
View From The Horizon: Pricing And Financial Regulation Of Health Products In France
On June 27 the third edition of our new global series, Life Sciences and Health Care Horizons, took place in Paris with discussions focused on the pricing and financial regulation of health products
France
31 Jul 2019
14
New Human Genetic Resources Regulations In China
On 28 May 2019, the People's Republic of China State Council promulgated the People's Republic of China Human Genetic Resources
China
23 Jul 2019
15
CDRH Issues Final Rule On Appeals, Excluding De Novos From 517A
On 2 July 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final rule1 updating the processes for appeal of certain FDA decisions related to medical devices regulated
United States
18 Jul 2019
16
Balancing Safety And Efficiency: Updating The Regulation On Pharmaceuticals And Medical Devices
It's been five years since both the name and the content of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the "Act")
Japan
12 Jul 2019
17
Fuelling Healthcare Innovation: Poland Creates New Medical Research Agency
In March 2019, the new law creating a Medical Research Agency ("the Agency") entered into force in Poland. This new entity is intended to play a similar role to institutions like the UK's Medical
Poland
12 Jul 2019
18
The European Commission Releases An Updated Borderline Manual For Medical Devices
The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual)
Belgium
3 Jul 2019
19
View From The Horizon: Artificial Intelligence And Cannabusiness In London
On May 16 the second edition of our new global series, Life Sciences and Health Care Horizons, took place in London featuring two panel discussions that focused on the challenges
UK
27 Jun 2019
20
HHS Announces Public Meeting On Ways To Accelerate Clinical Innovation
The U.S. Department of Health and Human Services' (HHS) Immediate Office of the Secretary (IOS) has announced it will hold a public meeting June 20-21 to seek public input
United States
19 Jun 2019
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