Regulatory Roundup, Week of Dec. 3, 2012

The International Conference on Harmonization (ICH) has announced that the Steering Committee has endorsed a revision of both the S1 Concept Paper and Business Plan. The revised documents include the S1 strategy to prepare a draft “Regulatory Notice for Public Input” for the solicitation of public comments with a final notice to be published in June 2014. 

FDA has released the following guidance documents:

• Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs, Guidance, Center for Drug Evaluation and Research (CDER), December 2012. The guidance summarizes the investigational new drug application process for unapproved PET drugs.

• FDA Oversight of PET Drug Products, Questions and Answers, CDER, December 2012. The guidance is intended to help producers of PET drugs meet FDA requirements for drug approval processes.

• Guidance for Industry, Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use—Small Entity Compliance Guide, CDER, December 2012. This guidance is intended to help small businesses understand and comply with FDA’s labeling and testing regulations of OTC sunscreen drug products.

• Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products, CDER, December 2012. This guidance provides CDER’s current thinking on the potential human health risks associated with exposure to dibutyl phthalate and di (2-ethylhexyl) phthalate.