Drug Labeling

Drug Labeling

Our team of full time professional staff and expert consultants are well-versed in the nuances of professional and promotional labeling including website review.

The product labeling communicates safety information, and serves as the basis of advertising and promotional labeling. This includes many other types of prescriber and patient materials such as communications with healthcare professionals, pharmacists, and patients, and other educational and promotional materials (written, electronic, mass media, etc.) Experience has taught that pre-marketing clinical trial data provide only initial and preliminary safety information for a new drug product. Following approval, the use of new drugs in larger and more diverse patient populations and the continuation of product use for protracted periods of time, often leads to the appearance of new adverse events, increases the frequency of previously observed events, and the emergence of new drug interactions. Drug companies are expected to amplify their product labeling if new evidence arises from post-approval reports and studies. This is critically important for Warnings-related information and/or if new study data relating to at-risk or vulnerable populations are realized.

PDG labeling recommendations are in use on currently marketed products. PDG will assist you in drafting and/or revising the following:

  • Professional Labeling for Prescribers
  • Medication Guides
  • Risk Evaluation and Mitigation Strategies (REMS)
  • Patient Labeling
  • Nonprescription (OTC) Drug Facts
  • Dear Healthcare Professional Letters
  • Promotional Labeling
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