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Searching Content indexed under Healthcare by Jones Day ordered by Published Date Descending.
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1
United States
26 Mar 2019
2
Food, Dietary Supplement & Cosmetics Regulatory Update | Vol. III, Issue 14
The FDA answered a series of questions concerning the compliance dates for various nutrition initiatives, such as the Nutrition Facts Label final rule and the vending machine labeling rule.
United States
2 Nov 2016
3
FDA Bans Sale Of OTC Antiseptic Wash Products Containing Certain Active Ingredients
Industry has one year to comply with the rule, which will become effective on September 6, 2017.
United States
19 Sep 2016
4
APHIS Issues Interim Rule to Amend Bovine Tuberculosis Regulations
This action relieves certain restrictions on the interstate movement of cattle and bison from the state of California.
United States
22 Aug 2016
5
MHRA Publishes Statistics On Early Access To Medicines Scheme
The tables also show the number of applications that have been granted (17) and refused (four), as well as the number of pending (five) applications.
United States
12 Aug 2016
6
French Publish Study On Safety Of Medical Devices Software
On July 13, 2016, the French national Agency for Medicines and Health Products Safety published a study on the safety of medical devices software.
European Union
12 Aug 2016
7
EMA Completes Zydelig Review
The PRAC's recommendations will now be passed to EMA's Committee for Medicinal Products for Human Use, or CHMP, for adoption of the Agency's final position.
European Union
12 Aug 2016
8
EU Publishes Guide On Zika And Substances Of Human Origin
The guide identifies concrete activities to be considered at the local, national, and EU levels.
European Union
12 Aug 2016
9
MHRA Publishes New Guidance On Remanufacturing Of Single-Use Devices
On July 5, 2016, the MHRA published new guidance on the remanufacturing of single-use devices ("SUDs") and expectations for their use.
United States
11 Aug 2016
10
Infringement Procedure Against Roche—EMA Update
The Agency's review has not identified any important new safety concerns and has not led to any changes in the terms of the marketing authorizations of these medicines.
United States
11 Aug 2016
11
EU Commission Consults On App Safety
The consultation is open for comments until September 15, 2016.
European Union
11 Aug 2016
12
FDA Issues Technical Specifications Document For Quality Metric Data
The document provides technical recommendations for submitting quality metric data.
United States
11 Aug 2016
13
FDA Announces Public Workshop On Medical Device Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, And Servicing
In the July 18, 2016, Federal Register, FDA announced a public workshop titled "Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers."
United States
10 Aug 2016
14
FDA Announces Public Workshop On ICH Guideline Q3D Regarding Elemental Impurities
In the July 8, 2016, Federal Register, FDA announced a public workshop titled "Regional Public Workshop on ICH Q3D Implementation of Guideline for Elemental Impurities."
United States
10 Aug 2016
15
FDA Proposes Rule Regarding OTC Antiseptic Drug Products
In the June 30, 2016, Federal Register, FDA proposed an amendment to its 1994 tentative final monograph for OTC antiseptic drug products (originally published in the June 17, 1994.
United States
10 Aug 2016
16
Post-Brexit: EMA And MHRA Issue Statements On The Outcome Of The UK Referendum
Following the UK referendum on whether to remain or leave the EU, the EMA as well as the UK's competent authority for medicines, the Medicines and Healthcare products Regulatory Agency, have both issued statements.
European Union
10 Aug 2016
17
CMS Issues Guidance On Value-Based Purchase Agreements And Best Price
In the notice, CMS stated that a VBP arrangement's impact on a drug's best price will vary based on the structure of the VBP arrangement.
United States
9 Aug 2016
18
First Financial Penalty Decision By The French ANSM
On May 19, 2016, the French National Drug and Health Product Authority ("ANSM") posted on its website its first two financial penalty decisions, adopted on May 12, 2016.
France
22 Jul 2016
19
EMA Publishes Report On Regulation Of Advanced Therapy Medicines
The report details concrete proposals to encourage development and authorization of ATMPs in the EU.
European Union
22 Jul 2016
20
New EU Rules On Medical Devices
On May 25, 2016, the EU agreed on new rules on medical devices and in vitro diagnostic medical devices—almost four years since the European Commission first published its proposal.
European Union
20 Jul 2016
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