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The FDA has revised its guidance on protecting drug and device research subjects in order to help institutional review boards (IRBs), clinical investigators and sponsors fulfill their responsibilities to protect human subjects in clinical trials.
Data generated by a patient-reported outcome (PRO) instrument can provide evidence of a treatment benefit from the patient perspective, according to an FDA draft guidance that explains how drug sponsors may use PRO-generated data to support Rx labeling claims.
The FDA has issued a series of revised guidances to help institutional review boards (IRBs), clinical investigators and sponsors fulfill their responsibilities to protect human subjects in clinical trials.
The FDA has issued a series of revised guidances to help institutional review boards (IRBs), clinical investigators and sponsors fulfill their responsibilities to protect human subjects in clinical trials.
A standoff between the Centers for Medicare & Medicaid Services (CMS) and drug companies over whether patient assistance programs violate anti-kickback laws is leaving low-income seniors on the verge of losing industry assistance to pay for their medications when they sign up for the Medicare Rx benefit.
Pharmaceutical and device manufacturers are concerned that the Agency for Healthcare Research and Quality’s (AHRQ) initiative to recommend preferred treatment options for a variety of health conditions could limit access to some medical therapies, especially if AHRQ focuses unduly on costs.
The FDA is expected to formally release its long-awaited list of priorities for changing the drug development process within the next 30 days, pending agreements between the agency, the NIH and academics, according to a high-ranking FDA official.
The FDA is expected to formally release its long-awaited list of priorities for changing the drug development process within the next 30 days, pending agreements between the agency, the NIH and academics, according to a high-ranking FDA official.
While praised by the pharmaceutical industry, the FDA’s latest plan to accelerate clinical trials to get more drugs in the pipeline is facing a backlash from some lawmakers and advocacy groups who point to the proposal as evidence the agency is too close to industry and does not place enough emphasis on public health.