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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Asia Regulatory Roundup: CFDA Offers Draft Guidance on Generic Drug Manufacturing Inspections (3 January 2017) By Nick Paul Taylor - Published 03 January 2017

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, Drugs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, CFDA guidance, generic drug inspections, codeine

Asia Regulatory Roundup: India Adopts Risk-Based Approach to Biologic Licenses (20 December 2016) By Nick Paul Taylor - Published 20 December 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, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, India biologic licenses, cashless economy

Asia Regulatory Roundup: CFDA Shifts to Random Inspections (6 December 2016) By Nick Paul Taylor - Published 06 December 2016

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

Categories: News, Asia, ANZTPA, CDSCO, CFDA, Medsafe, TGA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: GMP pharmaceutical manufacturing, Chinese drug inspections, DTAB, Sugam, Asia Regulatory Roundup

Asia Regulatory Roundup: India Begins Reviewing Drug Recall Guidelines (29 November 2016) By Nick Paul Taylor - Published 29 November 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, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: drug recalls, medicinal cannabis, antidiabetic

Asia Regulatory Roundup: TGA Consults on Accelerated Assessments for Devices (22 November 2016) By Nick Paul Taylor - Published 22 November 2016

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

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

Tags: Asia Regulatory Roundup, accelerate assessments medical devices

Asia Regulatory Roundup: Vietnam Drug Agency Adds Aurobindo, Other Indian Drugmakers to Blacklist (15 November 2016) By Nick Paul Taylor - Published 15 November 2016

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

Categories: News, Asia, CDSCO, CFDA, MHLW, TGA, Biologics and biotechnology, Drugs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: drug advertising, social media and pharmaceuticals, Aurobindo Pharma

Asia Regulatory Roundup: CFDA Offers Device Monitoring Guidance (1 November 2016) By Nick Paul Taylor - Published 01 November 2016

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

Categories: News, China, India, CDSCO, CFDA, MHLW, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices

Tags: Asia Regulatory Roundup, adverse event monitoring, device standards, radioactive drugs

Asia Regulatory Roundup: CFDA Investigates Trial Sites Over Data Integrity (25 October 2016) By Nick Paul Taylor - Published 25 October 2016

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

Categories: News, Asia, CDSCO, CFDA, Clinical, Crisis management, Drugs, Due Diligence, Medical Devices

Tags: Asia Regulatory Roundup, data falsification, Indian medical device rules

Asia Regulatory Roundup: CFDA Releases Draft Guidance on Data Management (18 October 2016) By Nick Paul Taylor - Published 18 October 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Drugs, Labeling, Quality

Tags: Asia Regulatory Roundup, GSK, Abbott, data management

Asia Regulatory Roundup: India Looks to Meet WHO Standards for GMPs (11 October 2016) By Nick Paul Taylor - Published 11 October 2016

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

Categories: News, Asia, CDSCO, CFDA, WHO, Active pharmaceutical ingredients, Clinical, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, DCGI, India, GMPs, clinical trial applications in India

Asia Regulatory Roundup: Australia to Adopt 10 EMA Guidelines (4 October 2016) By Nick Paul Taylor - Published 04 October 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, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, Australia drug manufacturing inspections, China medical devices

Regulatory Recon: Novo Nordisk to Cut 1,000 Jobs; Congress Passes $1.1B in Zika Virus Funds (29 September 2016) By Zachary Brennan - Published 29 September 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Europe, US, CDSCO, FDA, NICE, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Asia Regulatory Roundup: CFDA Continues Crackdown on Dishonest Drug Manufacturers (27 September 2016) By Nick Paul Taylor - Published 27 September 2016

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

Categories: News, Asia, CDSCO, CFDA, MHLW, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, DCGI, China medical devices, CFDA enforcement

CDSCO Advances Draft Medical Device Rules, Outlines Fees By Michael Mezher - Published 26 September 2016

India's Central Drugs Standard Control Organization (CDSCO) on Monday released an updated version of its draft rules for medical devices, including fees payable by industry, after consultations with stakeholders.

Categories: News, India, CDSCO, Medical Devices

Tags: Fees, Draft Medical Device Rules 2016

Asia Regulatory Roundup: TGA Offers Guidance on High-Risk IVD Online Applications (13 September 2016) By Nick Paul Taylor - Published 13 September 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Crisis management, Drugs, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: Pakistan controlled substances, CFDA on devices, TGA committees

ICH and Pharmaceutical Inspection Co-operation Scheme: No Expectations for China or India to Join By Zachary Brennan - Published 12 September 2016

While China and India continue to supply most of the world with pharmaceuticals (and continue to be plagued by quality and data integrity concerns), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and International Council on Harmonisation (ICH) – two of the largest international pharmaceutical regulatory schemes – say neither China nor India has any plans to join either group in the near future.

Categories: News, Asia, Europe, US, CDSCO, CFDA, FDA, ICH, Compliance, Crisis management, Drugs, Manufacturing

Tags: ICH, PIC/S, data integrity, pharmaceutical guidance, international pharmaceutical harmonization

Asia Regulatory Roundup: India Continues Clinical Trial Reform Agenda (6 September 2016) By Nick Paul Taylor - Published 06 September 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, Clinical, Drugs, Quality

Tags: Asia Regulatory Roundup, DCGI, CFDA guidance, metformin

Asia Regulatory Roundup: India’s DCGI Orders Manufacturers to Assess GMP, GLP Compliance (30 August 2016) By Nick Paul Taylor - Published 30 August 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, Clinical, Crisis management, Drugs, Government affairs, Human cell and tissue

Tags: TGA, DCGI, GLP, GMP, stem cells

Regulatory Recon: Roche’s Zika Test Wins Emergency Authorization From FDA (29 August 2016) By Zachary Brennan - Published 29 August 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, CDSCO, FDA, FTC, MHRA, NICE, Biologics and biotechnology, Clinical, Drugs, Government affairs, Manufacturing

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Asia Regulatory Roundup: CFDA Revises Preclinical Guidance (23 August 2016) By Nick Paul Taylor - Published 23 August 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Drugs, Due Diligence, Preclinical

Tags: Asia Regulatory Roundup, preclinical guidance, CFDA reforms

Regulatory Explainer: Everything You Need to Know About Biosimilars By Zachary Brennan - Published 10 August 2016

For more than a decade now, biotech and pharmaceutical companies have brought a new class of treatments – biosimilars – to markets around the world (from the EU to India to South Korea to the US), offering cost savings for some of the most expensive medicines, though even in 2016, decades after companies began their quest to develop biosimilars, they are still only just beginning to see widespread adoption.

Categories: News, Africa, Asia, Europe, US, CDSCO, EMA, FDA, FTC, Health Canada, MHRA, Biologics and biotechnology, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: biosimilars, BPCIA, patent dance, biologics, biosimilar savings

Asia Regulatory Roundup: India Allows Parallel Submission of Trial Filings for Insulins, mAbs (9 August 2016) By Nick Paul Taylor - Published 09 August 2016

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, Business Skills, Drugs, Quality, Regulatory intelligence, Regulatory strategy

Tags: DCGI, insulin, RCGM, mAb, Asia Regulatory Roundup

India Looks to Further Ease Process of Running Clinical Trials By Zachary Brennan - Published 02 August 2016

India’s Central Drugs Standards Control Organization (CDSCO) on Tuesday looked to relax two clinical trial requirements that could make it easier to run trials there.

Categories: News, India, CDSCO, Clinical, Research and development

Tags: clinical trials in India, clinical investigators

Asia Regulatory Roundup: Quality Issues Push TGA to Seek New Source for Angina Drugs (2 August 2016) By Nick Paul Taylor - Published 02 August 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Drugs, Medical Devices, Quality

Tags: Angina, Arrow Pharmaceuticals, drug manufacturing inspections, DRAP, NPPA