Brief description of the documents required for ANDA submission

DEALING WITH POST APPROVAL CHANGES- SUPAC 1 | Wasim Raja.S Sri Venkateswara College of Pharmacy Overview  What are SUPAC documents  Key SUPAC documents for quality…

1. Post approval of drugs 2.  Holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) who intend to make post approval changes should follow…

1.Proposal 15% Oct 3 POST to AnmL site before class on Group Forum500 word max. (not a word more)& PITCH (10 min.) IN STUDIO: “ What Why Who Where When” & Brainstorm…

1.Our goal is to become the worldwide standard for the way social media marketing is measured and optimized. 2. Businesses are going social 1,7 billion people use Social…

1. Saving Man’s Best Friend Matthew Liu The rise of Pet Pharmaceuticals Pomona College; March 30, 2014 2. Main Proposal • Creating our “ETF” or bucket of “pure”…

1. Late-phase study names 2. Observational, Evidence Based Medicine 3. Outcomes, REMS 4. Phase IV, Post Approval 5. Post Marketing, Real World Studies 6. Real World EDC Unique…

1. 1 2. 2 3. 3 4. 4 5. 5 6. Ir. Robert Ang Huck Koon Bachelor of Engineering Head of Structural Engineering Division Ir. Bobby Soon Bachelor of Civil Engineering Head of…

1. 1 2. 2 3. 3 4. 4 5. 5 6. Ir. Robert Ang Huck Koon Bachelor of Engineering Head of Structural Engineering Division Ir. Bobby Soon Bachelor of Civil Engineering Head of…