Drug Development Consultant & Regulatory Consultant

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

damienbove — Sun, 05 Feb 2012 13:26:30 +0000

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

damienbove — Sat, 04 Feb 2012 13:22:04 +0000

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 IDEs and INDs for Repair or Replace Knee Cartilage

damienbove — Thu, 02 Feb 2012 13:17:00 +0000

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

damienbove — Tue, 31 Jan 2012 10:57:29 +0000

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 Continue reading →

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

damienbove — Sun, 08 Jan 2012 08:55:15 +0000

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

damienbove — Sat, 07 Jan 2012 08:51:42 +0000

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

damienbove — Fri, 06 Jan 2012 08:47:31 +0000

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

damienbove — Thu, 05 Jan 2012 08:43:09 +0000

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

NICE Publish Guidnace on Tocilizumab for the Treatment of Systemic Juvenile Idiopathic Arthirits

damienbove — Wed, 04 Jan 2012 08:37:30 +0000

NICE has published guidance on the treatment of systemic juvenile idiopathic arthritis in children and young people aged two years and older whose disease has responded inadequately to non-steroidal anti-inflammatory drugs, systemic corticosteroids and methotrexate.

If the manufacturer of Tocilizumab makes it available at discount agreed as part of the patient assessment screen then nice recommends it for use in this patient group.

It is not recommended that children and young people of disease continues to response to methotrexate or who have not been treated with methotrexate.

Children already taking tocilizumab and do not meet these criteria should have the option of continuing treatment until it is considered appropriate to stop.

for guidance given below

NICE Publish Guidnce on Anaphlyaxis, assessment, confirmation and treatment

damienbove — Tue, 03 Jan 2012 08:37:03 +0000

Anaphylaxis is a severe life-threatening generalised systemic hypersensitivity reaction. Emergency department personel percented with a person displaying the signs ora symptoms may be classed as having a severe allergic reaction rather than an anaphylactic reaction. These NICE published guidelines intended to assist anybody who presents with such signs and symptoms to be classified as a suspected anaphylactic reaction and therefore should be diagnosed having a suspected anaphylaxis.

After an acute anaphylactic reaction it is believed that many people do not receive optimal management of their condition. One reason for this is healthcare professionals lack of understanding when making diagnosis. Another reason is a lack of understanding of when or where to refer patients. This can impact on the likelihood that the patient receives a definitive diagnosis and treatment this guideline is developed to address the situation.

Full Guidance Presented Below