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Filtering on: "organizations agencies/organizations cdsco"

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Asia Regulatory Roundup: Australia Scraps Target Date for Processing GMP Applications (25 April 2017) By Nick Paul Taylor - Published 25 April 2017

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

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

Tags: Asia regulatory roundup, GMP applications, stents, antimicrobial resistance

Asia Regulatory Roundup: India Looks to Reform Drug Pricing Legislation (18 April 2017) By Nick Paul Taylor - Published 18 April 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, In vitro diagnostics, Medical Devices, Regulatory strategy

Tags: Asia regulatory roundup, India drug pricing, CFDA clinical trial, China drug regulations

Asia Regulatory Roundup: CFDA Increases Drug Regulation Budget by 31% (11 April 2017) By Nick Paul Taylor - Published 11 April 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, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: data integrity, DCGI, pharma manufacturing, DRAP, stents

Asia Regulatory Roundup: Australia Considers Some DTC Drug Ads (4 April 2017) By Nick Paul Taylor - Published 04 April 2017

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, Research and development

Tags: drug advertising, oxytocin, DRAP

Asia Regulatory Roundup: India Offers Fast-Track Approvals to HIV, Hepatitis Combo Products (28 March 2017) By Nick Paul Taylor - Published 28 March 2017

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

Categories: News, Asia, CDSCO, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Asia regulatory roundup, fast-track approvals, combination products, antibiotic resistance

Asia Regulatory Roundup: India Proposes Platform to Monitor Drug Supply Chain (21 March 2017) By Nick Paul Taylor - Published 21 March 2017

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, Government affairs, Postmarket surveillance

Tags: Asia regulatory roundup, India drug supply, TGA pharmacovigilance

Asia Regulatory Roundup: Pfizer Asks TGA to Rethink Timeline for Biologics AE Reporting (14 March 2017) By Nick Paul Taylor - Published 14 March 2017

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, Pfizer, NPPA, stents

Asia Regulatory Roundup: TGA Increases Inspections Following Adoption of Risk-Based Approach (7 March 2017) By Nick Paul Taylor - Published 07 March 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, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, TGA inspections, NPPA

Asia Regulatory Roundup: J&J, Novartis and Pfizer Comment on Australian Risk Management Proposals (28 February 2017) By Nick Paul Taylor - Published 28 February 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, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, Pfizer, J&J, Novartis, stents

Asia Regulatory Roundup: India Applies Price Controls on Stents (21 February 2017) By Nick Paul Taylor - Published 21 February 2017

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, Government affairs

Tags: stents in India, substandard drugs, complementary medicines

Asia Regulatory Roundup: India Asks China to Expedite GMP Inspection to Resolve a Drug Shortage (14 February 2016) By Nick Paul Taylor - Published 14 February 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, Government affairs, Manufacturing

Tags: Asia Regulatory Roundup, drug shortage, GMP inspection, India online portal

Asia Regulatory Roundup: India Adopts New Medical Device Regulations (7 February 2017) By Nick Paul Taylor - Published 07 February 2017

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

Categories: News, Asia, CDSCO, CFDA, MFDS, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: India medical device regulations, DRAP, TFDA

Asia Regulatory Roundup: CFDA Offers Guidance on Security of Connected Devices (31 January 2017) By Nick Paul Taylor - Published 31 January 2017

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

Categories: News, Asia, CDSCO, CFDA, MHLW, PMDA, TGA, Drugs, Government affairs, Medical Devices

Tags: CFDA guidance, DCGI, DRAP, Pakistan stents

Asia Regulatory Roundup: CFDA Offers Technical Guidance on Clinical Trials (24 January 2017) By Nick Paul Taylor - Published 24 January 2017

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

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

Tags: Asia Regulatory Roundup, clinical trial guidance, import licenses, advisory committees

Asia Regulatory Roundup: China Unveils Reforms to Simplify Supply Chains, Lower Drug Costs (18 January 2017) By Nick Paul Taylor - Published 18 January 2017

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

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

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