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Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Chiang Ling Li ordered by Published Date Descending.
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1
Jones Day Global Privacy & Cybersecurity Update | Vol. 21
Data privacy- and security-related class actions appear to be on the rise, and effectively defending them requires the right mix of substantive and procedural knowledge.
Worldwide
11 Mar 2019
2
EMA Updates Organizational Structure
It is not anticipated that interactions between stakeholders and the Agency will be affected by these changes.
European Union
29 Sep 2016
3
EMA Consults On Development Of Medicines To Treat Tuberculosis
The guidance is an addendum to EMA's guideline on the evaluation of medicines to treat bacterial infections.
European Union
29 Sep 2016
4
EMA Consults On Modeling And Simulation In The Development And Regulatory Review Of Medicines
EMA has published a draft guideline to support and guide the use of innovative modeling and simulation approaches that are currently being used during the development of medicines.
European Union
29 Sep 2016
5
Proposals To Revise Guidance On First-In-Human Clinical Trials
EMA is proposing changes to current guidance on first-in-human clinical trials with the aim of improving strategies to identify and mitigate risks to trial participants.
European Union
28 Sep 2016
6
EMA Publishes Report On Adaptive Pathways Pilot Project
EMA has published a final report on the experience gained during its pilot project on adaptive pathways, a product development concept for medicines that address patients' unmet medical needs.
European Union
28 Sep 2016
7
European Commission Publishes Revised Medical Device Guidance On Stand-Alone Software
The European Commission has published a revised version of its Guidelines on Qualification and Classification of Stand-Alone Software ("MEDDEV 2.1/6"), which replaces the earlier 2012 version.
European Union
28 Sep 2016
8
New EMA Guidance On Data Integrity
EMA has released new good manufacturing practice guidance aimed at ensuring the integrity of data generated in the process of testing, manufacturing, packaging, distributing, and monitoring medicines.
European Union
28 Sep 2016
9
UK's MHRA Issues Guidance On Health Apps
On August 25, 2016, MHRA issued updated guidance to help identify the health apps that are medical devices and make sure they comply with regulations and are acceptably safe.
UK
28 Sep 2016
10
UK's MHRA Launches FakeMeds Campaign With Warning On Diet Pills
The campaign provides practical information on how to recognize legitimate online retailers of medicines and medical devices.
UK
27 Sep 2016
11
French ANSM Issues Guidance On Pilot Phase Clinical Trials
The purpose of the pilot phase is to ensure that France is ready when the European Regulation comes into force.
European Union
27 Sep 2016
12
EMA Workshop On Genetically Modified T-Cells
People interested in participating are invited to register using the form available on the website.
European Union
27 Sep 2016
13
New EMA Guidelines On Good Pharmacovigilance Practices
The GVP guidance was effective on August 16, 2016.
European Union
27 Sep 2016
14
EU And US eHealth IT Roadmap
The foreseen activities for this new work stream are outlined in the annex to the roadmap and will start in fall/autumn 2016.
Worldwide
27 Sep 2016
15
FDA To Host Public Conference On Key Aspects Of Drug And Device Regulations
The meeting will be available via webcast, but there will not be a transcript available following the meeting.
United States
27 Sep 2016
16
FDA Proposes Expanding Scope Of Clinical Investigator Disqualification In Regulations For New Animal Drugs For Investigational Use
With this proposal, FDA intends to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.
United States
27 Sep 2016
17
FDA Proposes Revising Regulations For Good Laboratory Practice For Nonclinical Laboratory Studies
A GLP Quality System will provide the appropriate framework for building quality into a nonclinical laboratory study and will result in more reliable data for FDA to consider when making regulatory decisions.
United States
27 Sep 2016
18
FDA Reopens Comment Period For User-Fee Program For OTC Drugs
In the August 8, 2016, Federal Register, FDA announced it is reopening the comment period for the potential development of a user-fee program for nonprescription, or OTC, monograph drugs.
United States
27 Sep 2016
19
FDA Publishes User Fee Rates For FY2017
The fee rates are effective October 1, 2016, and will remain in effect through September 30, 2017.
United States
26 Sep 2016
20
FDA Announces Pilot Of Intercenter Consult Request Process For Combination Products
Last month, FDA announced the beginning of its intercenter consult request process that will be piloted across the Agency through 2017.
United States
26 Sep 2016
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