GUIDELINES ON SIMILAR BIOLOGICS

Manufacturing and Marketing permission issued …

S.No. Drug Name Indication Date of Approval 10 Everolimus tablets 2.5mg. 5mg and 10mg “Treatments of adults patients with progressive, well differentiated, non- ...

  Manufacturing, Marketing, Issued, Permission, Manufacturing and marketing permission issued

Annexure-1 GMP CHECKLIST

SOP No.: EP-INS-004 Page 1 Annexure-1 GMP CHECKLIST (Based on WHO Good Manufacturing Practices (GMP) for active pharmaceutical ingredients stated as per

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INVESTIGATIONAL MEDICINAL PRODUCT …

C:\Users\website\Desktop\pendency july\IMPD Template Quality.doc Last printed 8/18/2016 8:02:00 PM INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER FOR

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LIST OF NEW DRUGS APPROVED IN INDIA FROM …

LIST OF NEW DRUGS APPROVED IN INDIA FROM 1991 TO 2000 S. No Name of Drug Pharmacological action/ Indication Date of Approval 1 Ciprofloxacin 0.3% w/v Eye

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List of NABL Accredited Laboratories in India

Sr. No. Name of the Laboratory Nature of Lab Field Discipline Group Address Contact Details Organization Type 1 Alcatec Research Laboratories India Pvt.

(Medical Devices Division) - Central Drugs …

GUIDANCE DOCUMENT ON COMMON SUBMISSION FORMAT FOR IMPORT LICENSE OF NOTIFIED MEDICAL DEVICES. Page | 1 Guidance Document (Medical Devices Division)

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(Medical Devices and Diagnostic Division)

Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India

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LIST OF LICENSED BLOOD BANKS IN INDIA * …

LIST OF LICENSED BLOOD BANKS IN INDIA * (February, 2015) Sr. No. State Total No. of Blood Banks 1. Andaman and Nicobar Islands 03 2. Andhra Pradesh 140 3.

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SUMMARY OF PRODUCT CHARACTERISTICS

Summary of Product Characteristics lactating women may be considered after careful evaluation of the benefits and risks in case of a medical emergency or an epidemic.

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GUIDELINES ON RECALL AND RAPID ALERT SYSTEM …

Page 3 of 13 5.0 Recall Classification: Recall classification is a numerical designation, I, II, or III, that is assigned to a particular product recall that indicates the relative degree of health hazard by country

  Recall

Guidelines on Similar Biologic: Regulatory Requirements ...

Guidelines on Similar Biologic: Regulatory Requirements for Marketing Authorization in India _____ 11.

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Science Moving towArds Research Translation and Therapy ...

3 5 Diana Severynse-Stevens, PhD Director, Drug Development, RTI Anita Woodring, MS, RAC Clinical Regulatory, Drug Development, RTI Dana Minnick, PhD, RAC

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IRB Review of Recruitment Materials - Schulman IRB

IRB Review of Recruitment Materials Engaging Subjects Responsibly & Ethically December 10, 2014 Presented by: Kim Looney and Ashley Dixon IRB Members, Schulman Associates IRB

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