GMP News, GMP guidelines, GMP Violations, GMP warnings A Public Health Global News Portal

Welcome to gmpviolations.com FDA, WHO, EU, TGA, CDSCO guidelines...and GMP Violations news/warning letters..

150000+ Industry Leaders already read it everyday

Monday, August 29, 2016

FDA Publishes Antibacterial Drug Development Guidance

Image result for FDA

The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.FDA published guidance on Aug. 25, 2016 regarding microbiology data in antibacterial drug development. The guidance addresses FDA’s recommendations for a microbiology development program to support development and approval of antibacterial drugs and the collection of postapproval information.

The guidance outlines a microbiology development program. It specifically addresses early development nonclinical considerations, including antibacterial spectrum of activity, mechanism of action, intracellular antimicrobial concentration assessment, and resistance studies. In-vitroantimicrobial susceptibility test methods used during drug development are also discussed. The guidance also addresses first and second lists of target bacteria in labeling, antibacterial interactions and fixed combination studies, animal models of infection, microbial information collected in clinical trials, and electronic submissions.
Image result for cLICK BELOW .pdf download
Share:

0 comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...

AMAZON BEST DEALS

Popular Posts

AMAZON BEST DEALS

Subscribe Free GMP Guidelines

Enter your email address:

Delivered by FeedBurner

Followers

Printfriendly

Subscribe via email for free

Services

Enter your email address:

Delivered by FeedBurner

Contact Form

Name

Email *

Message *

Menu :
Powered by Blogger.

Visitors

    Translater

    Related Posts Plugin for WordPress, Blogger...

    Category

    2016 (37) 2017 (85) 2018 (9) 211 CFR (1) 211.63 (1) 483 (5) AAFA (1) Abbott (2) AboutUs (1) ALCOA (1) Alerts (2) ANDA (1) Anshu (2) Antibiotics (1) apic (1) APR17 (8) APS (2) Articles (4) AstraZeneca (1) Aug17 (2) Aurobindo (2) Author (2) Authors (8) Biocon (1) cadila (1) capa (3) CDSCO (5) Change control (1) Christian Green (1) cipla (2) Cleaning validation (1) Data Integrity (9) dec16 (15) Definations (1) Deviations (1) Donald Trump’s (2) Downloads (17) Dr.Reddy's (4) eca (1) EIR (1) Eli Lilly (1) ema (12) EU (9) FDA (70) FDA Guide (18) FEB17 (15) Genaral (1) General Health (2) GMP (1) GMP News (36) gsk (2) GuidelineEU (10) GuidelinesG (5) GuidelineW (2) GV/0117/001 (1) GVAuthors (3) Health (4) HOSPIRA (1) ICH (3) ICHGuide (3) import alert (1) India (1) ISPE (1) James Bullock (1) JAN17 (23) Jul17 (8) July17 (1) Jun17 (4) Lupin (2) Mahender (39) MAR17 (13) Mar18 (7) May17 (10) MHRA (3) MHRA guide (1) Mumbai (1) Mylan (4) Natco (1) News (55) Non Complinaces (1) Nov16 (5) Novartis (1) oct (1) Oct16 (10) OCT17 (1) PDA (1) Personnel (1) pfizer (1) pics (8) Picsguide (2) QbD (1) Quality Docs (1) RCA (1) Recall (1) safety (1) Sanjeev Kumar Singh (4) Sanofi (1) Sep16 (6) Siegfried Schmitt (2) SUN (1) TGA (3) TOP 10 PHARMA (1) USP (2) Validation (3) Warning Letters (43) WHO (6) zika (1)

    Sponsors

    Theme Support