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Posted 06 January 2015 | By Alexander Gaffney, RAC,
The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has released a new list of 90 guidance documents it plans to publish in 2015, including several long anticipated and eagerly awaited by members of the pharmaceutical industry.
The list, Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015, is published annually by FDA (2012, 2013, 2014), and is meant to outline FDA's regulatory workload as it relates to pharmaceutical and biological products.
However, guidance documents, unlike regulations, serve to clarify how FDA expects to enforce regulations—not set new ones.
The latest Guidance Agenda contains several guidances of particular note. FDA says it plans to release four biosimilar guidance documents in 2015, including how biosimilar products should be labeled. FDA also plans to release or finalize six advertising guidance documents, including one on the use of healthcare economic information, and another one on how companies can use third-party links on social media.
Manufacturing, too, seems to be an area of particular focus to FDA in 2015. Planned guidances include one on how to "modernize the pharmaceutical manufacturing base" using emerging technologies, another on "quality metrics and risk-based inspections," and another one focused on data integrity—a particular issue for foreign-based inspections.
FDA has also planned to issue or finalize six guidance documents on track and trace as part of the Drug Supply Chain Security Act (DSCSA). The agency recently gave drug companies until May 2015 to comply with the law, which was supposed to go into effect on 1 January 2015.
FDA also plans to issue a guidance on the Sunscreen Innovation Act (SIA), a law passed in late 2014 that aims to speed up the pace at which new sunscreen ingredients can come to market.
Other guidances of note include one describing "Common Issues in Drug Development for Rare Diseases," the inclusion of pregnant women in clinical trials, how to evaluate the effect of a drug on a patient's ability to operate a motor vehicle, and several regarding risk evaluation and mitigation strategies (REMS).
The full list may be found below:
Tags: Guidance, Guidance Agenda, 2014 Guidance Agenda, Final Guidance, Draft Guidance