Tag Archives: patients

FDA Commissioner Califf to Industry at #BIO2016: Talk to Patients

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Industry should work with patients and their advocates to better understand their experiences, what they’re looking for in a therapy, and their tolerance for risk, US Food and Drug Administration commissioner Robert Califf emphasized during a fireside chat at the BIO International Convention this afternoon. For the past few years FDA has been meeting with patients and patient advocates to better understand their diseases and medical problems and asking them where regulatory efforts should be Read More >

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Expanding the Role of Patients in Drug Development

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Working alongside scientists, universities, and biotech companies, patients and patient organizations have the ability to play a critical role in the search for treatments and cures for chronic and deadly diseases.  As part of the 5th authorization of the Prescription Drug User Fee Act (PDUFA V), the Food and Drug Administration made a commitment to more systematically gather patients’ perspectives on their condition and the available therapies in order to incorporate these findings into their Read More >

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More Than 90 Patient Organizations Urge Congress to Protect Patients and Innovation

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Today, the Epilepsy Foundation and a diverse group of more than 90 advocacy organizations submitted a letter to the House and Senate Judiciary Committees urging Congress to maintain a strong and secure patent system that encourages investments in innovative treatments and devices as it considers comprehensive patent reform. Together, our organizations represent millions of individuals waiting for the next breakthrough treatment, and hopefully, cure. Without strong patents, many innovative ideas will not make it from the Read More >

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BIO Principles on Expanded Access to Investigational, Unapproved Medicines

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Seriously ill patients with limited or no alternative therapies, and who are ineligible or unable to participate in the clinical trials, may desire access to investigational, unapproved medicines.  Such access outside of the clinical trial setting, or “expanded access,” may be sought through a company’s expanded access program, or through individual patient expanded access, if available. We believe that the best way to make innovative biotechnology medicines available to patients is through the efficient development of approved, safe Read More >

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Coalition Offers a Remedy for Stagnated Clinical Trials

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Promising new clinical trial data offers fresh hope for the families of Alzheimer’s patients.  A new medication seems to be slowing the disease’s progress, limiting the cognitive decline that characterizes this “long goodbye.” Wouldn’t it be wonderful for patients suffering other diseases to have equally encouraging prospects? But many do not. Part of the problem lies with clinical trials.  For a new medication to receive FDA approval, it must undergo comprehensive testing on actual patients.  Read More >

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