PMID- 26261845
OWN - NLM
STAT- MEDLINE
DCOM- 20160104
LR  - 20181202
IS  - 1699-3993 (Print)
IS  - 1699-3993 (Linking)
VI  - 51
IP  - 7
DP  - 2015 Jul
TI  - Generic Pharmaceutical Association (GPhA) - 2015 CMC Workshop (June 9-10, 2015 - 
      Bethesda, Maryland, USA).
PG  - 429-40
LID - 10.1358/dot.2015.51.6.2371796 [doi]
AB  - Nearly 400 professionals attended the 2-day Generic Pharmaceutical Association 
      (GPhA) workshop dedicated to fostering discussions on the FDA's chemistry, 
      manufacturing and controls (CMC) expectations for abbreviated new drug 
      applications (ANDAs), enhanced regulatory filing requirements, and other topics, 
      as CMC takes root in the Office of Pharmaceutical Quality (OPQ). Following the 
      keynote address by Janet Woodcock, Director of the FDA's Center for Drug 
      Evaluation and Research (CDER) and Acting Director of OPQ, and an update from the 
      Office of Generic Drugs (OGD) by Ted Sherwood, Acting Director of the OGD's 
      Office of Regulatory Operations, plenary sessions took place covering OPQ 
      updates, management plans, Generic Drug User Fee Amendments of 2012 (GDUFA) 
      backlog, year 1 and 2 cohorts, drug substance, defining starting materials, 
      quality related refuse-to-receive standards, risk and team-based integrated 
      quality assessment, deficiencies and information requests - CMC submissions, 
      emerging technologies, compliance and inspection, lifecycle management of drug 
      products, quality metrics, pharmaceutically relevant dissolution specifications, 
      and communication and project management. This report will provide a summary of 
      conference highlights.
CI  - Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.
FAU - Komlos, D
AU  - Komlos D
AD  - Thomson Reuters, Gaithersburg, Maryland, USA. deborah.komlos@thomsonreuters.com.
LA  - eng
PT  - Congress
PL  - Spain
TA  - Drugs Today (Barc)
JT  - Drugs of today (Barcelona, Spain : 1998)
JID - 101160518
RN  - 0 (Drugs, Generic)
SB  - IM
MH  - *Drugs, Generic/adverse effects
MH  - Humans
MH  - Risk Assessment
MH  - Societies, Pharmaceutical
MH  - United States
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - ANDAs
OT  - CMC
OT  - FDA
OT  - GDUFA
OT  - Generic drugs
EDAT- 2015/08/12 06:00
MHDA- 2016/01/05 06:00
CRDT- 2015/08/12 06:00
PHST- 2015/08/12 06:00 [entrez]
PHST- 2015/08/12 06:00 [pubmed]
PHST- 2016/01/05 06:00 [medline]
AID - 2371796 [pii]
AID - 10.1358/dot.2015.51.6.2371796 [doi]
PST - ppublish
SO  - Drugs Today (Barc). 2015 Jul;51(7):429-40. doi: 10.1358/dot.2015.51.6.2371796.