'Abbreviated new drug application' presentation slideshows

DRUG MASTER FILES

DRUG MASTER FILES. / 45. CONTENTS:-. Introduction Some basic terminologies. Types of DMFS with their contents. Submissions to drug master files Authorization to refer to a drug master file Processing and reviewing policies Holder obligations

2.11k views • 45 slides

Michael A. Swit, Esq. Vice President

Michael A. Swit, Esq. Vice President. FDA Regulatory Considerations for Life Sciences Companies Swedish-American Chamber of Commerce E-Days Life Sciences Program April 9, 2008 San Diego, California. Standard Disclaimers.

413 views • 30 slides

FDA Regulatory Considerations for the Biomedical Start-Up

FDA Regulatory Considerations for the Biomedical Start-Up . LARTA CAP Program Newport Beach, CA October 7, 2005. Michael A. Swit, Esq. Vice President, Life Sciences. Establish FDA Strategy Early!!. Some considerations follow . . . FDA's Three Key Development Roles:.

425 views • 28 slides

Regulatory requirements on Medicine Stability Guidelines relevant for Stability testing

Regulatory requirements on Medicine Stability Guidelines relevant for Stability testing. Sultan Ghani. Focus of The Presentation. Regulatory Considerations Guidelines relevant for stability testing Highlights of new WHO Stability Guidelines . Regulatory Considerations.

1.23k views • 23 slides

Center for Professional Advancement Generic Drug Approvals Course

311 views • 19 slides