US Food and Drug Administration – The FDA is committed to making sure that health care professionals and patients have up-to-date, accurate and actionable information about prescription medications so that informed treatment decisions can be made.
The Wall Street Journal – A bipartisan group of state attorneys general is jointly investigating the marketing of prescription painkillers and the causes of widespread opioid addiction, in another sign of growing pressure on the pharmaceutical industry.
Bloomberg – The Food and Drug Administration, as part of a sweeping overhaul in how it regulates opioid painkillers, plans to look to some unusual allies to limit the flood of the addictive pills -- health insurers and companies that manage prescription drug benefits.
This guidance is intended to assist applicants in writing the DRUG ABUSE AND DEPENDENCE section of the labeling, as described in the regulations for the content and format of labeling for human prescription drug and biological products.
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