NCHR Testimony at the FDA Pregnancy Registries Meeting

May 28, 2014. Pregnancy exposure registries tend to be too small and have often not recruited sufficient numbers of racial and ethnic minorities. The biggest challenge is obtaining information on a drug’s safety during pregnancy as quickly as possible after a new drug is marketed.

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Coalition Comments to FDA Urging Stronger FDA Guidelines on Drug Ads

May 2, 2014. We strongly oppose the guidance. These guidelines are aimed at clarifying guidelines developed before the law regarding distributing scientific and medical publications on unapproved new uses (off-label) of medical products sunset in 2006. It fails to follow the law or to protect patients and the public health.

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