Author Archives: damienbove

EMA published a draft update appendix 1 on the guidelines on the evaluation anticancer medicinal products in man

This draft guideline deals with the methodological considerations fusing progression free survival (PFS) disease-free survival (DFS) in confirmatory trials.

The use of PFS and DFS as endpoint in clinical efficacy trials present several methodological issues that need to be addressed. This draft guidance hopes to provide some regulatory guidance on these issues specifically referring to definitions, frequency and methods of assessment ascertainment bias handling of deviations and missing data and finally radiological review.

The guidance goes into details of defining the clinical endpoints and how they should be implemented. More details can be found in the embedded draft document below.

 

EMA publishes community herbal monograph on Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix

The EMA has published this community herbal monograph on herbal medicinal products, HMPC, community herbal monographs, traditional use,Urtica dioica L., Urtica urens L. This is now the standard for use in registered herbal medicinal products in Europe.

EMA calls for scientific data for use in HMPC assessment work on Crataegus monogyna Jacq.(lindm.) or Crataegus laevigata (Poir.) D.C., fructus

The HMPC invite all people with an interest in the herbal product registration and the development of the herbal products monograph for Crataegus monogyna Jacq.(lindm.) or Crataegus laevigata (Poir.) D.C., fructus to submit scientific data, either published or unpublished that can be used in the review of this herbal medicine. Full details are given below in the embedded PDF

EMA call for scientific data for use in HMPC assessment work on Ginkgo Biloba L., folium

The HMPC invite all interested parties to submit scientific papers and information for use as part of the assessment of Ginkgo Biloba L., folium

full details can be found in embedded PDF below

 

ATMP Regulations in Europe

ATMP European Regulations Review.

There are Mind Maps to Accompany these videos, you can get them by sending a blank email to ATMP@damienbove.com

ATMP Regulations in Europe, a roadmap to clinical trial and product approval in Europe for Advanced Technologies. Such as tissue engineering, stem cell work and genetic engineering

You need to be logged in to see this part of the post. Please Login here.
bloglink ATMP Regulations in Europe Join the forum discussion on this post

EMA Publish Opinion on HMPC Herbal Mongraph for Capsella bursa-pastoris (L.) Medikus, herba

To be published on the main EMA site

EMA make a call for scientific data for use in assessment of Ginko biloba L., folium

The herbal medicinal product committee of the DMA invite all interested parties such as pharmaceutical industry Association, healthcare professional groups, learned societies consumers and patients associations to submit any scientific data that they feel will be relevant to the assessment of  Ginko biloba L., folium as part of the establishment of community herbal monograph.

Health Canada releases draft guidance on classification of observations for inspection of cells, tissues and organs establishments

Health Canada has released a draft guidance to assist with companies become compliant with the safety of human cells, tissues and organs for transplantation regulations which came into force on 7 December 2007. The purpose of this regulatory initiative is to minimise the potential health risks to Canadian recipient of human cells and tissues and organs. And to ensure that such organisations remain compliant with the proposed regulations.

More information is available on the Health Canada website

Health Canada opens consultation on cleaning validation guidance

Health Canada has opened the consultation process to provide guidance on issues and topics related to the validation of equipment cleaning the removal of contaminants associated with previous products, residues of cleaning agents as well as control of potential microbial contaminants. This guidance is for pharmaceuticals biologicals and radiopharmaceutical product manufacturers. The purpose of this guidance is to ensure that such manufacturers remain compliant with good manufacturing practice (GMP).

more information can be found on the Health Canada website

Health Canada publish new regulations on process validation for terminal sterilisation of pharmaceutical products

The draft guidelines outlined in process validation: terminal sterilisation processes pharmaceutical products (GUI – 0074) applied to the validation of sterilisation of raw materials, packaging materials, and finished products pharmaceutical and veterinary drugs.

This guidance is to ensure that companies remain within compliance of good manufacturing practice (GMP)

More information is published on the health Canada website

FDA publish updated guidance on current good tissue practice (CGTP)

The FDA is issuing this guidance to provide establishments that manufacture human cells, tissues, and cellular tissue-based products with recommendations complying with current good tissue practice (CGTP).

This is to ensure that all of these establishments can remaining compliance with 21CFR part 1271 subpart D and subpart E

FDA publish guidance on the use of histology in biomarker qualification studies

This guidance is for sponsors who wish to conduct biomarker qualification studies which use histology as a reference standard. It gives people guidance on processes that should be considered to ensure quality and integrity of the data in the biomarker studies and outlines the scientific standards should be used in biomarker characterisation and qualification. It is intended to provide recommendations support the proposed context of use where scientifically rigourous evaluation is essential. This applies to exploratory biomarker studies, but not to nonclinical safety assessment studies.

FDA publish guidance on responding to unsolicited requests for off label information about prescription drugs and medical devices

The FDA is published guidance on the current thinking on how manufacturers and distributors of prescription medicines and devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use generally known as off label information related to FDA approved products.

FDA Publish Guidance on IDEs and INDs for Repair or Replace Knee Cartilage

This guidance document provides answers of investigational device exemption application (IDE) on investigational new drug application (IND) recommendations about the information they need to include within their submission on describing their products but is intended to replace or repair knee cartilage.

This guidance supplements other recommendations in the area of drugs and biologicals and devices provide recommendations specific to cartilage repair or replacement. the FDA considers these products a significant risk area, and requires you to have specific approval from the FDA conducting research in this area. Advice from the institutional review board is no longer sufficient.

Normal Service to Resume Soon

Apologies to my readers the site has gone quite in January, I have been on Paternity leave so unable to update the site, I have started recruiting an assistant to keep on-top of things but as yet not had much luck. Normal service resumes in February.

Best Regards

Damien

FDA publishes guidance on responding to unsolicited requests for off label information

This guidance is a representation of the FDA’s current thinking how manufacturers and distributors of prescription human and animal drug products and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off label information).

This updates previous guidance and clarifies FDA’s policies, in light of emerging electronic media.

Full guidance reproduced below:

NICE published detailed review of service user experience in adult mental health

The report subtitled proven experience of care for people using adult NHS mental health services is published by NICE and is aimed to advise on improving the experience of care for people using mental health services.

The report delivers a number of recommendations and has been developed by multidisciplinary team of health care professionals, service users, their carers and guidance methodologiesafter careful consideration of the best available evidence.

Although the evidence business area is continually expanding the number of major gaps and future revisions of this guidance will incorporate new scientific evidence as it develops.

This guidance goes on to make a number of research recommendations specifically to address gaps in the evidence base.

This highly detailed report is available to download from the following link NICE report

NICE published guidance on Elucigene FH20 and LIPOchip for the diagnosis of familial hypercholesterolaemia

Elucigene FH20 and LIPOchip are not recommended for the confirmation of the clinical diagnosis in people with familial hypercholesterolaemia because greater benefits can be achieved cost effectively through the use of comprehensive genetic analysis. They are also not recommended for Cascade testing relatives of people with confirmed familial hypercholesterolaemia because targeted sequencing is less expensive and can be used with no loss of health benefits.

Full guidance given below

NICE published guidance on Panitumumab in combination with chemotherapy for metastatic colorectal cancer

NICE is unable to recommend the use of Panitumumab in the NHS in combination with chemotherapy for the treatment of metastatic colorectal cancer. The manufacturer did not submit any evidence to NICE during this technology evaluation.

This evaluation relates only to wild-type KRAS metastatic colorectal Cancer first-line treatment with FOLFOX and second-line treatment in combination with FOLFIRI for patients who received first line fluoropyrimidine-based chemotherapy.

full guidance given below

NICE Publish Guidance on the use of Fulvestrant for the treatment of locally advanced or metastatic breast cancer

Fulvestrant it’s not recommended, with its licensed indication, as an alternative to aromatase inhibitors for the treatment of oestrogen receptor positive, locally advanced metastatic breast cancer in postmenopausal women whose cancer has relapsed on or after adjuvant anti-oestrogen therapy, or who have disease progression on anti-oestrogen therapy.

Postmenopausal women currently receiving this drug should have the option to continue treatment until they or their clinicians consider it appropriate to stop.

full guidance given below