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TN govt appoints M N Sridhar as state licensing authority & controlling authority for DC department

AuroBlog - Aurous Healthcare Clinical Trials blog

The Tamil Nadu government has appointed the incumbent controlling authority (CA) of the drugs control administration, M N Sridhar, as state licensing and controlling authority (SLA and CA) for the department of drugs control from June 18 onwards.

Licensing 231
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Licensing regime posing challenge to micro and small medical devices industry: SMTA

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central government’s actions to mandate licensing of all medical devices is posing a challenge to the industry, especially the micro and small enterprises in the sector, says the Surgical Manufacturers and Traders Association (SMTA), the pan India organisation of manufacturers and traders of surgical equipment for healthcare services providers (..)

Licensing 189
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Centralisation of drug licensing may not be the right path to improve quality of drugs: SPIC

AuroBlog - Aurous Healthcare Clinical Trials blog

Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)

Licensing 189
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Psychedelic clinical trials: What sponsors should know when designing new protocols

Worldwide Clinical Trials

BioPharma Dive interviewed our Christine Moore on how to conduct psychedelic clinical research. With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area. These trials are often someone’s last hope,” Moore said.

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CDSCO releases draft guidance document on stability studies of IVD Medical Devices

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.

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How to Ensure Patient Safety During a Clinical Trial

Cloudbyz

Monitoring patient safety during a clinical trial is one of the founding principles to be followed throughout the drug development life cycle. It can be defined as a collaborative relationship between sponsors, sites, researchers, and everyone involved in the clinical trial phases.

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Ultimate Guide To Clinical Trial Costs

Clinical Trial Podcast

Have you been tasked to develop a clinical trial budget? Well, you’re in luck because I’m going to share everything you need to know about clinical trial costs. Clinical trial budgets are often put together in haste. Developing a clinical trial budget can be a confusing exercise for sponsors and CROs.