Tag Archive
The following is a list of all entries tagged with Regulations:
Drug Regulators, MHRA, Publish Consultation, Intention to Amend the Medicines for Human Use Regulations 2008 (SI2008/1692)
Filed in marketing, February 12, 2010, 11:41 amThis consultation notifies interested parties that further amendments will be made to the Medicines For Human Use (Prescribing By EEA Practitioners) Regulations 2008
(2008 Regulations). This consultation seeks views on how current guidance can be expanded to provide additional support for community pharmacists following forthcoming legislative changes.
FDA introduces new Rules of IRB Registration
Filed in clinical,regulatory, July 23, 2009, 9:34 amThe FDA IRB Registration Rule is effective Tuesday, July 14, 2009. All IRBs reviewing FDA-regulated research must register between July 14 and September 14, 2009.
Non GMP stock allowable for Human Radiolabled PK studies
Filed in clinical,formulation,regulatory, June 25, 2009, 9:26 amSince 2004, there has been a clear requirement to manufacture the IP (drug product) to Good Manufacturing Practice (GMP), however the quality standard required for the radiolabelled Active Pharmaceutical Ingredient (API) was open to interpretation.
MHRA guidance on the vigilance systems for medical devices- Intraocular lenses
Filed in Uncategorized,devices,regulatory, June 22, 2009, 9:22 amThis guidance document gives advice to manufacturers on the notification of adverse incidents involving intra-ocular lenses under medical devices the chilling system. It includes, but is not limited to, the following types of intraocular lenses: posterior chamber; phakic; anterior chamber; multifocal; and accommodated. It is intended to facilitate uniform application implementation of the medical devices directive.
MHRA publishes guidance on the Medical Devices Directives
Filed in Uncategorized,clinical,devices,regulatory, June 1, 2009, 9:55 amThe MHRA has published Guidance on the EC Medical Devices Directives. The guidance document is a comprehensive document, and covers the regulations in some detail:
FDA guidance – Submission of Bioequivalence data for ANDA’s
Filed in clinical,formulation,regulatory, May 18, 2009, 8:31 amThis guidance is intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) in complying with FDA’s new requirements for the submission of bioequivalence (BE) data.
FDA Draft Guidance – Label Comprehension Studies for Non-prescription Drug Products
Filed in Uncategorized,clinical,manufacturing, May 3, 2009, 5:20 pmThe Food and Drug Administration (FDA) often requires sponsors to conduct label comprehension studies that are designed to evaluate proposed nonprescription drug product labeling. This guidance is intended to provide recommendations to industry on conducting label comprehension studies
GMP for phase 1, or not GMP as the case may be.
Filed in clinical,manufacturing,regulatory, April 7, 2009, 1:58 pmThe FDA has set a trend towards the reduction of GMP reduction in phase 1 clinical trials with the publication of guidlines “CGMP for Phase 1 investigational drugs”, this was published in july 2008
Bioequivalence of Therapeutic Proteins
Filed in biotechnology,clinical,regulatory, March 25, 2009, 10:37 amThe EMEA is the only regulator to introduce regulations, these regulations make it clear that biosimilars are not the same and are not regulated in the same was as generic drugs
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