Tag Archives: claims

Drug Regulators, FDA, CDER, Publish Guidance on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

Posted on December 29, 2009 by admin| Leave a comment

Drug Regulators, FDA, CDER, Publish Guidance on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

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This guidance describes how the Food and Drug Administration (FDA) reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO) instruments used to support claims in approved medical product labeling. A PRO instrument (i.e., a questionnaire plus the information and documentation that support its use) is a means to capture PRO data used to measure treatment benefit or risk in medical product clinical trials. This guidance does not address the use of PRO instruments for purposes beyond evaluation of claims made about a medical product in labeling. This guidance also does not address disease-specific issues. Guidance on clinical trial endpoints for specific diseases can be found on various FDA Web sites.
By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their discussions with the FDA during the medical product development process, streamline the FDA’s review of PRO instrument adequacy and resultant PRO data collected during a clinical trial, and provide optimal information about the patient perspective for use in making conclusions about treatment effect at the time of medical product approval. PRO instrument development is an iterative process and we recognize there is no single correct way to develop a PRO instrument. Different strategies and methods can be used to address FDA review issues.
The Glossary defines many of the terms used in this guidance. Words or phrases found in the Glossary appear in bold italics at first mention. Specifically, we encourage sponsors to familiarize themselves with the terms conceptual framework of a PRO instrument, endpoint model, and content validity.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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ida consultants freestrategyconsultation 515x64 Drug Regulators, FDA, CDER, Publish Guidance on Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

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Drug Regulators, EMEA, Publish Concept Paper on the Need for Clinical Guidelines for the Investigation of Medicinal Products for the Treatment of Systemic and Cutaneous Lupus Erythematosus

Posted on December 26, 2009 by admin| Leave a comment

Drug Regulators, EMEA, Publish Concept Paper on the Need for Clinical Guidelines for the Investigation of Medicinal Products for the Treatment of Systemic and Cutaneous Lupus Erythematosus

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Lupus erythematosus is usually divided into two main types: cutaneous (CLE) and systemic lupus erythematosus (SLE).
The main clinical form of CLE is chronic cutaneous (or “discoid”) lupus erythematosus (DLE). The risk of a patient with DLE to develop SLE is small (1,3% in localised DLE, overall 5-6%, around 20% during the lifetime in disseminated DLE). Despite some haematological and serological abnormalities, patients are in good health. The age and sex distribution of SLE is strikingly different from that of DLE. Therefore, patients with DLE are not a subset of patients with SLE waiting for a disease to develop but can be considered as a separate entity.
There are also patients with other forms of cutaneous LE, such as lupus panniculitis and subacute cutaneous LE; these forms are rare, and more frequently associated with SLE.
DLE is characterised with well-defined erythematous patches with a fairly adherent scale (the forms without scaling are called “lupus tumidus”) which tend to clear with atrophy, scarring and pigmentary changes. The histology is characteristic. Highly potent topical steroids, intralesional steroids, antimalarials (in addition to topical steroids) are given to control the activity of the skin disease and to prevent scarring. Small doses of systemic steroids may be given in some patients.
Systemic lupus erythematosus (SLE) is a multisystem autoimmune disease characterized by production of autoantibodies and involvement of multiple organ systems (SLE 1997 revised American College of Rheumatology classification criteria apply).
SLE appears as a group of related syndromes, with widely varying presentation, body system involvement, and clinical course. The clinical course of SLE is episodic, with activity flares recurring upon increasing disability and organ damage. Corticosteroids (typically prednisone or prednisolone) remain the foundation for long-term control of disease activity, in association with anti-malarials and immunosupressants .Other drugs often used as supportive or adjuvant treatment include analgesics, NSAIDs,, vasodilators (calcium channel blockers, ACE inhibitors) for renal hypertension or Raynaud’s syndrome ischemia, local treatments for rashes or sicca syndromes, transfusions, intravenous globulin for cytopenias, anticonvulsivants, antimigraine medications, anticoagulants for recurrent thromboses, and antidepressants.
High-dose steroids, such as pulse IV methylprednisolone, and immunosuppressants, are standard treatment for management of an acute flare.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators, EMEA, Publish Concept Paper on the Need for Clinical Guidelines for the Investigation of Medicinal Products for the Treatment of Systemic and Cutaneous Lupus Erythematosus

ida 100programme 515x64 LowRes Drug Regulators, EMEA, Publish Concept Paper on the Need for Clinical Guidelines for the Investigation of Medicinal Products for the Treatment of Systemic and Cutaneous Lupus Erythematosus

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Functional Foods Overstep the Claims – are Cheerios a drug? the FDA think so

Posted on May 14, 2009 by admin| 1 Comment

General mills the manufacture of Cheerios has been issued with a a warning letter from the FDA for “serious violations” of the FDC act in the label and labeling of Cheerios cereal, there lies a lesson in this for other companies making functional food claims.

the FDA claims that the following label claims make Cheerios an unapproved drug under FDC Act# 505(a), as they indicate that the cereal is intended to prevent, mitigate, and treat hypercholesterolemia.

  • “you can Lower Your Cholesterol 4% in 6 weeks”
  • “Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is … clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol.”

And because the website is given on the packaging and that goes on to make more claims these are also treated as labelling. This is no new issue in the food industry but the FDA has done very little enforcement of the rules but that appears to be changing, is this a shot across the bows of the food industry.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug  development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

ida consultants freestrategyconsultation 515x64 Functional Foods Overstep the Claims are Cheerios a drug? the FDA think so

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