Search Results for CDSCO

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Asia Regulatory Roundup: CFDA Offers Guidance on Device Quality Control (10 January 2017) By Nick Paul Taylor - Published 10 January 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, PMDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: AstraZeneca, Bristol-Myers Squibb, Merck, CDSCO, codeine

Asia Regulatory Roundup: India Caps Prices of Drug-Eluting and Bare-Metal Stents (26 July 2016) By Nick Paul Taylor - Published 26 July 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Business and Leadership, Drugs, Ethics, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: CDSCO, stent prices, vaccine storage, Indonesia vaccines

India Releases New Biosimilars Guidance By Zachary Brennan - Published 28 March 2016

India’s Central Drugs Standard Control Organization (CDSCO) on Saturday released new guidance for biosimilar developers as new biosimilars come to market there before other regions, and as India's regulators look to develop more specific guidance on postmarketing studies.

Categories: News, India, Korea, CDSCO, Biologics and biotechnology, Clinical, Government affairs, Manufacturing, Postmarket surveillance

Tags: biosimilars, biosimilar guidance, CDSCO guidance, India biosimilars, Herceptin

India's Supreme Court Denies Petitions Challenging CDSCO By Zachary Brennan - Published 11 March 2016

Dinesh Thakur, the now-famous Ranbaxy whistleblower who won more than $48 million for calling out the company’s drug safety issues to the US Department of Justice, failed on Friday to get the Supreme Court of India to take up two petitions seeking to challenge the law under which India’s drug regulator Central Drugs Standard Control Organization (CDSCO) operates.

Tags: Supreme Court of India, Dinesh Thakur, CDSCO, India drug regulation

FDA Begins Training Hundreds of Indian Regulators By Zachary Brennan - Published 24 February 2016

The push to get India’s pharmaceutical and medical device regulators up to speed with international norms and the US Food and Drug Administration’s (FDA) regulations is progressing with new cooperative training sessions.

Categories: News, India, CDSCO, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Manufacturing, Medical Devices

Tags: CDSCO, FDA training, FDA in India

India’s CDSCO Warns Against Using Roche’s Avastin as Eye Treatment By Zachary Brennan - Published 21 January 2016

India’s Central Drugs Standards Control Organization (CDSCO) issued an alert Thursday notifying state and local authorities that Roche’s blockbuster drug Avastin has not been approved to treat any ophthalmology conditions and can lead to vision loss.

Categories: News, India, CDSCO, Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance

Tags: Avastin, Roche, Novartis, Lucentis, Genentech, CDSCO

Asia Regulatory Roundup: India Pushes Back Track and Trace Deadline Again (12 January 2016) By Nick Paul Taylor - Published 12 January 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, Biologics and biotechnology, Clinical, Drugs, Labeling, Manufacturing, Regulatory strategy

Tags: CDSCO, India, CFDA, track and trace

Asia Regulatory Roundup: China Looks to End Regional Variation in Trial Oversight (22 December 2015) By Nick Paul Taylor - Published 22 December 2015

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, ANZTPA, CDSCO, CFDA, IMDRF, Medsafe, MFDS, PMDA, TGA, Biologics and biotechnology, Clinical, Distribution, Drugs, Due Diligence, Government affairs, Manufacturing

Tags: Asia regulatory affairs, CFDA, TGA, CDSCO, PMDA

Asia Regulatory Roundup: CFDA Chips Away at Backlog of Applications (15 December 2015) By Nick Paul Taylor - Published 15 December 2015

Welcome to our Asia Regulatory Roundup, a weekly overview of the top regulatory news in Asia.

Categories: News, China, India, Japan, Korea, Taiwan, CDSCO, CFDA, MHLW, Biologics and biotechnology, Clinical, Distribution, Drugs, Ethics, Government affairs, Manufacturing, Medical Devices, Quality

Tags: CFDA, CDSCO, Korean biosimilars, drug applications

Asia Regulatory Roundup: China, US Agree to Clear Drug, Device Application Backlogs (1 December 2015) By Nick Paul Taylor - Published 01 December 2015

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, US, CDSCO, CFDA, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Project management, Regulatory intelligence, Regulatory strategy

Tags: China, US, Malaysia, MDA, CDSCO, India

Asia Regulatory Roundup: CFDA Clampdown on Clinical Trial Data (17 November 2015) By Nick Paul Taylor - Published 17 November 2015

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, PMDA, TGA, Clinical, Drugs, Quality, Regulatory intelligence, Regulatory strategy

Tags: CFDA, CDSCO, India, China, regulatory news

India’s CDSCO Offers Four New Updates to Promote Clinical Research By Zachary Brennan - Published 10 November 2015

India’s Central Drugs Standard Control Organization (CDSCO) issued four new circulars on Tuesday that all seek to help promote clinical research on the subcontinent.

Categories: News, India, CDSCO, Clinical, Drugs, Preclinical, Quality, Regulatory intelligence, Regulatory strategy

Tags: India, CDSCO, clinical trials, toxicology, preclinical, NOC, academic research

FDA Form 483s From India: A Deep Dive Into the Problems By Zachary Brennan - Published 09 November 2015

A Focus review (thanks to the Freedom of Information Act) of 50 Form 483s issued by the US Food and Drug Administration (FDA) to Indian pharmaceutical and active pharmaceutical ingredient (API) manufacturers over the past two years reveals a slew of detailed quality concerns from the agency.

Categories: News, India, US, CDSCO, FDA, Active pharmaceutical ingredients, Audit, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Quality

Tags: India, Form 483s, Wockhardt, Glenmark, Hospira, CDSCO, warning letters

Asia Regulatory Roundup: India Looks to Raise Drug Inspection Standards (20 October 2015) By Nick Paul Taylor - Published 20 October 2015

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, India, Japan, Middle East, Oceania, CDSCO, PMDA, TGA, Drugs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: CDSCO, DRAP, Pakistan, India, DCGI, marijuana, Australia

MHRA, CDSCO Sign Agreement to Increase Regulatory Collaborations Published 05 October 2015

As more drugs and active pharmaceutical ingredients (APIs) are manufactured in India, foreign regulators are increasingly looking to strengthen relations with India's Central Drugs Standard Control Organisation (CDSCO).

Categories: News, India, Europe, CDSCO, MHRA, Biologics and biotechnology, Combination products, Drugs

Tags: CDSCO, MHRA, India, UK, GMP inspections

India Unveils New Online Submission System for Clinical Trials By Zachary Brennan - Published 09 September 2015

India's Central Drugs Standards Control Organization (CDSCO) has launched a new online submission system for clinical trials as part of efforts to increase transparency, accountability and efficiency in processing trial applications.

Categories: News, India, CDSCO, Clinical

Tags: India, CDSCO, clinical trials, online submission system

India’s CDSCO Looks to Crack Down on Online Drug Sales By Zachary Brennan - Published 08 September 2015

An Indian government committee is looking to stem the spread of illegal sales of prescription medicines online.

Categories: News, India, CDSCO, Generic drugs, Prescription drugs

Tags: CDSCO, online pharmacies, FDA, Drugs and Cosmetics Rules, 1945