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5518dft

Biosimilars_QA Guidance on BPCI Act.pdf

16823dft

15085fnl.pdf

10745-fnl-04-24-15

10532dft_05-09-14

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2003guidance_redo_10-02-13(2).pdf

Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999

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old098fn.pdf

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2003guidance_redo_10-02-13(2).pdf

2013-246 draft.pdf

userfee.pdf

pdufa-irdr

Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act

Guidance for Industry User Fee Waivers, Reductions, and Refunds for Drug and Biological Products U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) September 2011 User Fees OMB Control

Guidance for Industry User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR

Guidance for Industry Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act

2360fnl

Dr. Reddy's Laboratories Ltd CTO India 01-20 through 28-2020_483.pdf

Dr. Reddy's Laboratories Ltd CTO India 01-20 through 28-2020_483.pdf

Biocon Ltd. Bangalore, India 01-20 through 24-2020_483.pdf

Biocon Ltd. Bangalore, India 01-20 through 24-2020_483.pdf

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Daman India 09.20 thru 29.16_483.pdf

Cosma SpA Ciserano, Italy 1-15-16 483.pdf

Cadila Healthcare Baddi India.pdf

CP Pharmaceuticals

Dr%2e Reddy's Unit 6 Srikakulam India 4%2e4%2e17

Daman India 09.20 thru 29.16_483

Cadila Healthcare Baddi India

Cosma SpA Ciserano, Italy 1-15-16 483.pdf

Aurobindo Pharma Unit 1 Telangana, India 10.25.16 483

Aurobindo Pharma Ltd. Unit 4 Hyderabad India 4.28.17 483

Ahmedabad India 8-16 Thru 26-16-483

ucm284690

ucm363761

Cpm High Potency

NEW Annex 3 Validation of Computers as Part of Tes (1)

NEW Aide Memoire for Environmental Conditions Trea (4)

Annex_4_Qualification_of_IR_spectrophotometers (1).pdf

EU-GMP-Vol4_Annex15.pdf

EU-GMP-Vol4_Annex2.pdf

ucm450021

ucm559676

ucm500960

ucm498880(1)