仿制化学药品研技术指导原则意见稿.docVIP

【 】 OO七年 月 目 录如果标准中未规定杂质限度，产品的杂质含量明显高于已上市的同品种的杂质实测值1. FDA Guidance for industry ANDAs: impurities in drug substances, Nov. 1999 2. FDA Guidance for industry Court decisions, ANDAs approvals, and 180-day exclusivity under the Hatch-Waxman amendments to the federal food, drug, and cosmetic act. Mar. 2000 3. FDA Guidance for industry 180-day exclusivity when multiple ANDAs are submitted on the same day. July 2003 4. FDA Guidance for industry Listed drugs, 30-month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended by the Medicare prescripti