At the end of 2015, the Center for Devices and Radiological Health (CDRH) published a list containing the guidelines planned for fiscal year 2016 (1st October 2015 - 30 September 2016) as well as older guidelines which might be updated. Learn more about the planned FDA Guidances.
In irregular intervals, the ECA publishes overviews of new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. Find out more about the current publications of the FDA.
Recently, the FDA has published a draft guideline on the determination of Quality Metrics. With regard to medical devices, the FDA is now pursuing a similar path. Under the heading "Case for Quality" (CfQ), the FDA would like to improve the quality of medical devices.
The FDA recently published a draft guidance for industry on the "Advancement of Emerging Technology Applications". The draft guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of CMC information containing emerging manufacturing (including testing, packaging and labeling, and quality control) technology to FDA. Find out more about the draft guidance for industry "Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base".
As part of its inspections, the FDA nowadays always examines the integrity of data. This can clearly be seen in the recent Warning Letter from December 2015. Besides, the letter focuses on the inappropriate handling of OOS results. Read more about the current FDA Warning Letter on Data Integrity.
The European Medicines Agency (EMA) has revised several modules and documents of the Guideline on good pharmacovigilance practices (GVP) and published them for comment, i.e. finalised a document. Read more about the GVP updates.
The European Medicines Agency (EMA) issued a draft guideline related to unwanted immune responses against therapetic proteins derived by biotechnological processes. Find out more about this EMA draft guideline.
The FDA adopted and published the Guidance for Industry "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products". Read more about these FDA recommendations.
In November, the FDA published a Guideline on formal requesting, planning and performing meetings with the Agency with regard to the development and submission of biosimilars. Find out more about the FDA Guideline on Good Meeting Management Practice.
Two FDA draft guidances regarding INDs have been published for comments in December 2015: "Best Practices for Communication Between IND Sponsors and FDA During Drug Development" and "Safety Assessment for IND Safety Reporting". Find out more about the draft guidances on investigational new drug applications (INDs).
Two documents of the EDQM regulate matters which haven't been covered by "public documents" so far. Read more about what has to be considered by applicants or holders of a CEP in case of personnel changes or complaints during a CEP procedure.
The FDA has recently published a new Guideline as a draft which describes the certification process of medical gases i.e. gases for direct administration to human beings or animals. Read more about the FDA Medical Gases Certification Guideline.
In the Pharmacopoeial Forum 42(1) a revised Draft of USP Chapter <670> Auxiliary Packaging Components was published for comments. Comment deadline is March 31, 2016. Read more about the revised USP Auxiliary Packaging Components Chapter <670>.
The MHRA GPvP inspectorate published their latest inspection metrics report for the period of April 2014 to March 2015. Read more about the findings identified during all 48 inspections conducted during this period.
In a previous News from October 2015, we pointed out that the FDA has been observing more and more deficiencies in the area of statistics with regard to process validation. One of the "statistical methods" - also stated in FDA's Process Validation Guideline - is the use of control charts in the context of a statistical process control (SPC). Learn more about the views of an FDA representative on the use of control charts.