Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Hogan Lovells ordered by Published Date Descending.
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New Draft Guidance On MR Compatibility For Medical Devices
The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."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
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
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
31 Jul 2019
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
23 Jul 2019
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
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
12 Jul 2019
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")
12 Jul 2019
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)
3 Jul 2019
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
27 Jun 2019
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
View From The Horizon: Digital Health And Cell, Tissue, And Gene Therapies In Boston
On April 30 our new global series, Life Sciences and Health Care Horizons, kicked off in Boston with two panel discussions that focused on the challenges ...
United States
7 Jun 2019
Survival Of The Fittest Or Cheapest?
T he past year is set to be a milestone year for China's pharmaceutical regulatory reform as the newly formed National Medical Products Administration (NMPA) continues to aggressively cut back on red
4 Jun 2019
FDA Doubles Down On MUsT Studies For Sunscreens And Issues Final Guidance On Absorption Studies That Will Likely Be Needed For Continued Marketing
On 10 May 2019 the U.S. FDA published a notice of availability for a final guidance document on Maximal Usage Trials for topically applied active ingredients being considered for OTC drug monographs...
United States
30 May 2019
New FDA Draft Guidance On Voluntary Recalls Highlights Importance Of Recall Initiation Plans
On April 23, FDA issued draft guidance entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C".
United States
27 May 2019
DOJ Issues New Guidance Regarding Cooperation In False Claims Act Investigations
Continuing its recent trend of revising and issuing new white collar enforcement guidance, the U.S. Department of Justice (DOJ) on Tuesday announced a new policy
United States
27 May 2019
Will Government's Approach To The Adoption Of The NHI Do More Harm Than Good?
The Minister of Health, Dr Aaron Motsoaledi (Minister), has been entrusted with the unenviable task of overseeing South Africa's transition to universal health coverage
20 May 2019
The French Competition Authority Issues Its Recommendations To Lower Prices Of Pharmaceutical Products
Almost one and a half years after the launch of the sector inquiry (see here), the French Competition Authority ("FCA") has released its conclusions on the functioning of competition in the pharmaceutical sector.
8 May 2019
Good Manufacturing Practice And The Global Supply Chain (Video)
Supply chain oversight: what to expect from —and how to prepare for— an increasingly global supply chain and heightened FDA scrutiny
United States
2 May 2019
Your QMS Supports Your Global Operations And We Are Prepared To Support You
Satisfying ISO 134851 is important for U.S. and international medical device firms. Companies selling in the EU must operate their quality management systems (QMS) in compliance
United States
30 Apr 2019
Regulator Proposes Reducing Requirements For Radiation-Emitting Products
In a welcome move, on 1 April 2019 the U.S. Food and Drug Administration (FDA) proposed reducing regulatory requirements for a number of radiation-emitting electronic products.
26 Apr 2019
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