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BY EMILY CUKIER-MEISNER, SENIOR WRITER
FDA’s draft guidance on Duchenne muscular dystrophy and related
dystrophinopathies is the culmination of an extensive e6ort led by a
patient advocacy group that enlisted the support of patients, caregivers,
academia and industry.
DMD drug development has been hindered by a lack of defined outcome
measures and understanding of surrogate markers or biomarkers that
Relationship Between Uric Acid and Erectile Dysfunction Uric acid is blamed to be the main culprit when it actually comes to gout and as such, it has become an interesting factor of concern while talking about lovemaking conditions including ED. cialis discount pharmacy People due to certain work load or stress tend to a victim of some worst issues which can be controlled through diet therapy and exercise therapy, the rest all need drug treatment. lowest price for viagra Suppose there was a female libido enhancer that would be just as effective. best soft cialis The effects are not for very long and are simply for the viagra prescription purpose of intercourse. could support approval. To address this, FDA invited Parent Project
Muscular Dystrophy (PPMD) and the DMD community to submit a
proposed draft guidance that could clarify a clinical development pathway
for approval.
FDA spokesperson Kristofer Baumgartner said in a statement to
BioCentury that PPMD’s submission is the first time in the Center for
Drug Evaluation and Research’s knowledge that an advocacy group has
submitted a proposed draft guidance, and that this type of engagement is
an example of how early input from patients and caregivers can contribute
to drug development.