November 7, 2016. A major problem for FDA communication is how it has become increasingly promotional, rather than providing objective information about the products that the FDA regulates. Similarly, FDA needs to do a better job of preventing misleading information and inadequate explanations of risk in direct-to-consumer ads.
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NCHR Letter to ACGME About Medical Residents’ Work Hours
October 13, 2016. We urge the ACGME to make patients’ lives a priority by keeping the first-year residents’ hours capped at 16 hours of continuous duty and to also apply the cap to all other residents.
Read More »NCHR Supports Increased User Fees for Generic Drugs
October 21, 2016. NCHR strongly supports increasing GDUFA and other user fees to improve FDA’s resources in order to enable the agency to fulfill its public health mission.
Read More »Public Health Advocates Support Tight FDA Restrictions on Pharmacy Compounded Drugs
October 11, 2016. NCHR strongly supports the draft guidance documents because they place tight restrictions on pharmacy compounding under sections 503A and 503B of the FD&C Act to prevent compounding drug products that are essentially copies of commercially available drug products and for those that are copies of approved drugs.
Read More »NCHR says YES to Ariel Grace’s Law
September 26, 2016. NCHR president Dr. Diana Zuckerman explains that the NCHR believes the bill is needed because “it provides an important incentive for manufacturers to do a better job of testing the safety of their implants and other devices. The incentive would be their desire to avoid law suits by patients harmed by defective high-risk medical devices.”
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