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Searching Content indexed under Food and Drugs Law by Chiang Ling Li ordered by Published Date Descending.
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1
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
2
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
3
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
4
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
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
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
7
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
8
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
9
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
10
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
11
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
12
FDA Continues To Refine Regulatory Approach For Compounding Pharmacies: "Essentially A Copy" Provisions And Inspection Protocol For Non-Outsourcing Facilities
FDA released two draft guidance documents setting forth the Agency's policies for applying the "essentially a copy" provisions of Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
United States
9 Aug 2016
13
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
14
First Medicines Approved Under EU's Priority Medicines Scheme
On June 1, 2016, EMA announced the outcome of the assessment of the first batch of applications received from medicine developers for its PRIME (PRIority MEdicines) scheme...
European Union
21 Jul 2016
15
Single, Central Platform Now Mandatory For All Periodic Safety Update Reports
The PSUR repository is a single, central platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the EU.
European Union
21 Jul 2016
16
EU Launches Four Clinical Trial Public Consultations
On June 1, 2016, the European Commission launched four public consultations in the field of clinical trials.
European Union
21 Jul 2016
17
UK Regulator Recalls Progesterone Produced By India-Based Akums Drugs And Pharmaceuticals
The Statement of Non-Compliance with GMP published on the EudraGMP website noted that one critical and three major deficiencies were uncovered during the inspection.
UK
21 Jul 2016
18
EMA Reflects On First-In-Human Clinical Trials Following Fatal Rennes Trial
The aim of EMA's work is to agree on a concept paper by July 2016 identifying areas for change and proposals to further minimize the risk of similar accidents.
European Union
20 Jul 2016
19
TTIP Update—Annex On Medicinal Products
On May 24, 2016, The European Commission published a proposal for an annex to the Transatlantic Trade and Investment Partnership ("TTIP") on medicinal products...
European Union
20 Jul 2016
20
FDA Issues Final Rule On Symbols In Labeling
In the June 15, 2016, Federal Register, FDA issued a final rule revising the Agency's medical device and certain biological product labeling regulations.
United States
19 Jul 2016
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