Remove Clinical Research Remove Licensing Remove Regulation
article thumbnail

CDSCO calls for timely reporting of adverse events related to medical devices to MvPI

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI), in the backdrop of shifting the segment to licensing regime.

In-Vitro 189
article thumbnail

e-pharmacies informed CDSCO they are only providing online platform connecting users & pharmacies: Minister

AuroBlog - Aurous Healthcare Clinical Trials blog

The Union ministry of health and family welfare has said that most of the e-pharmacies in the country have informed the Central Drugs Standard Control Organisation (CDSCO) that they are only providing an online platform connecting the users and the licensed pharmacies, in response to the show-cause notice from the drug regulator sent early this […] (..)

Pharmacy 189
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Centre puts onus on SLAs to take action against e-pharmacies for violation of D&C Act and Rules

AuroBlog - Aurous Healthcare Clinical Trials blog

With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.

Pharmacy 188
article thumbnail

Delhi HC grants 10 days’ time to Govt to file counter affidavit on petitions against ban of 14 FDCs

AuroBlog - Aurous Healthcare Clinical Trials blog

The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]

article thumbnail

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Worldwide Clinical Trials

Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes.

Trials 200
article thumbnail

Cloudbyz Recognized in Everest Group’s 2024 PEAK Matrix® for Life Sciences CTMS Solution

Cloudbyz

This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Global Regulatory Compliance: Ensures compliance with 21 CFR Part 11 and other global regulations, reducing compliance risks.

article thumbnail

The efficacy of Mental Health Apps

pharmaphorum

As few as 2% have peer-reviewed research to back up their claims. ”. These analyses focused exclusively on wellness and smoking cessation apps, bypassing a category of digital therapeutics regulated by the FDA that make scientifically validated claims using sound research. Consistent Standards Matter.