submitted within 60 days of publication in the Federal Register of the  

    notice announcing the availability of the draft guidance. Submit comments

    to the Division of Dockets Management (HFA-305), Food and Drug

    Administration,

    5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be

    identified with the docket number listed in the notice of availability that

    publishes in the Federal Register. Continue reading 

 personnel. The document does not bind FDA, and does not confer any

 rights, privileges, benefits, or immunities for or on any person(s).

 Continue reading

2. GMP 소식

 1) 의료기기의 허가‧신고‧심사 등에 관한 규정 일부개정고시안 행정예고

    식품의약품안전청 공고 제2012-265호

    「첨단의료복합단지 지정 및 지원에 관한 특별법」에 따라 첨단의료복합단지

    입주의료연구개발기관의 의료기기 허가를 지원하고, 부령 위임에 따라

    중고의료기기 검사필증 면제대상 및 판매업 신고가 면제되는 자가진단용

    의료기기를 규정하려는 것임 Continue reading  

 2) FDA Drug Safety Communication: Serious skin reactions after 

 combination treatment with the Hepatitis C drugs Incivek (telaprevir),

 peginterferon alfa, and ribavirin

 
    Safety Announcement
    [12-19-2012] The U.S. Food and Drug Administration (FDA) received

 reports of serious skin reactions, some fatal, in patients taking the

 hepatitis C drug Incivek (telaprevir) in combination with the drugs

 peginterferon alfa and ribavirin (Incivek combination treatment).

 Significantly, some patients died when they continued to receive Incivek

 combination treatment after developing a worsening, or progressive rash

 and systemic symptoms (symptoms affecting the entire body).

 Continue reading 

3. ISPE 국내, 외 소식

 1) ISPE 한국지부 송년회 

   ‣ 일시 : 2012년 12월 17일 (오후 5시)

    ‣ 장소 : 충북 오송

    ‣ 안건 : 2012년 성과 보고 및 2013년 계획 논의

    ‣ 참석 : ISPE 한국지부 회장 및 운영위원

 2) ISPE Announces 2012 Award Winners at Global Annual Meeting
   (TAMPA, FLORIDA, USA, 06 December 2012) – ISPE announced its 2012

   award winners at the Society’s Annual Meeting held in San Francisco, 

   Calif. USA 11 – 14 November. Recognizing the awardees’ contributions to

   ISPE and to the pharmaceutical industry, Nancy S. Berg, President and CEO,

   presented the honors on behalf of the ISPE Board of Directors.

   Continue reading