Aktualności
GMP: FDA´s New Regulations for Drug Manufacturers
29.09.2016
The US Food and Drug Administration (FDA) amends its requirements for foreign and domestic establishment registration and listing for human drugs, including drugs that are regulated under a
...
EMA: Concept paper for the revision of the note for guidance on the use of adjuvanted veterinary vaccines
29.09.2016
The Immunologicals Working Party (IWP) recommends revisiting the contents and replacing the note for guidance on the use of adjuvanted veterinary vaccines with a new guideline, to take into
...
URPL: Information of General Director of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 23, 2016 on the procedures for the access to the file of proceedings.
08.09.2016
This document is announcement of General Director of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of August 23, 2016 on the procedures for the access to
...
GMP: Effect of primary packaging on drug stability of solid dosage forms
08.09.2016
A stimuli article on The Effect of Primary Packaging on the Physical Degradation of Metformin, Lisinopril, and Simvastatin Solid Doses During Patient Use When Stored at Different Temperature and
...
GMP: New WHO guidance on variations to multisource pharmaceutical products
08.09.2016
The World Health Organizaton recently published a new Annex 10: WHO general guidance on variations to multisource pharmaceutical products. The document is \"intended to serve as a guide for
...
RAPS: DA Begins Process of Overhauling Off-Label Communications Regulations
08.09.2016
The US Food and Drug Administration (FDA) on Wednesday announced a new two-day public meeting to address a comprehensive review of its regulations and policies governing firms’ off-label
...
RAPS: FDA Calls for Boxed Warning on Two Drug Classes
08.09.2016
The US Food and Drug Administration (FDA) says it is requiring two classes of drugs, opioids and benzodiazepines, to bear a boxed warning over serious and sometimes fatal risks when the two drugs
...
RAPS: FDA Makes Drug Safety Labeling Change Information Easier to Access
08.09.2016
The US Food and Drug Administration (FDA) on Thursday announced the safety labeling changes (SLC) program will be managed by its Center for Drug Evaluation and Research’s (CDER’s) Office of
...
GMP: EMA - requirements for quality documentation concerning biological investigational medicinal products
08.09.2016
Already in 2012, the European Commission published a guideline on the quality documentation for IMP in clinical trials. Now on 23 June, the EMA issued a draft \"Guideline on the requirements for
...
FDA: E17 General Principles for Planning and Design of Multi-Regional Clinical Trials This
08.09.2016
With the increasing globalisation of drug development, it has become important that data from multi-regional clinical trials (MRCTs) can be accepted by regulatory authorities across regions and
...
