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Indian pharma sees immense importance in US FDA guidance on aluminum content and labelling in parenteral nutrition

AuroBlog - Aurous Healthcare Clinical Trials blog

Indian pharma sees immense value in US FDA’s insistence for aluminum content and labelling recommendations for the Small Volume Parenterals Drug Products and Pharmacy Bulk Packages. Pharma companies in the country have increasingly made a shift to nutritional based prescription and over the counter products.

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MindMed Adds Chief Development Officer with FDA Phase 2 Psilocybin Clinical Trial Experience

The Pharma Data

Barrow previously served as Director of Drug Development & Discovery at Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona’s development programs.

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Are microtaggants the key to making medicines smarter?

pharmaphorum

This technology can also play an important role in supporting virtual clinical trials. The threat of illegal online pharmacies. Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain.

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FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-Administration

XTalks

XTALKS WEBINAR: Accelerating Vaccines to Clinical Trials — A Toolkit for Efficacy, Safety and Bioanalytical Studies Live and On-Demand: Wednesday, November 15, 2023, at 11am EST (4pm GMT/UK) Register for this free webinar to gain insights into the challenges and innovations in mRNA vaccines in clinical trials.

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Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. For each drug regulatory authority, before a drug is approved, three phases of clinical trials of increasing complexity and scope in human subjects and proof that a drug will be manufactured correctly under Current Good Manufacturing Practices are required.

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RECOVERY Trial Data Monitoring Committee Recommends Continuing Evaluation of REGN-COV2 in All Hospitalized Patients

The Pharma Data

About the Trial The RECOVERY trial is conducted by the registered clinical trials units in the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

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Esomeprazole vs Omeprazole – Which one is BETTER?

Druggist

General sale medicines (GSL): available on sale in retail outlets and pharmacies, without a prescription. One study looked at all clinical trials and aided to see if esomeprazole is better than omeprazole in gastroesophageal reflux disease and Helicobacter pylori infection. Esomeprazole vs Omeprazole legal classification .

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