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Tag: Pharma

FDA Draft Guidance on Metallic or Calcium Phosphate Coatings: Non-Clinical Bench Testing | United States

The article describes in detail the approach to be applied with respect to non-clinical bench testing medical devices should undergo in order to collect...

FDA Draft Guidance on Metallic or Calcium Phosphate Coatings: Specific Aspects | United States

The article addresses specific aspects to be taken into consideration concerning premarket submissions for orthopedic devices with metallic or calcium phosphate coating, including the...

The Billion Dollar Psilocybin Patent Race – Can One Company Actually Patent the Psilocybin Molecule?

Psychedelics Pending Patents: Can A Company Own Psilocybin Forever and Ever? An interesting money grab is taking place in the psychedelics space as Cannabis.net first hinted...

AI Is Streamlining Quality Control in Medicine Manufacturing

Quality control is a crucial but inefficient process in most manufacturing applications. Medicine producers face even more challenges than most. Their quality standards are...

MDCG Guidance on Clinical Investigations: Content and Modifications | EU

The new article provides additional clarifications concerning the content of submissions associated with clinical investigations and modifications to it. Table of...

Serbian Guidance on Amendments to MD Registration: Overview | Serbia

The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party...

First-Ever Legal Exports of THC From Jamaica to the United States

MONTEGO BAY, Jamaica — Pure Jamaican and its GMP-certified, licensed pharma manufacturer Seven-10 Pharmaceuticals are elevating Jamaica’s role in the global cannabis supply chain by legally...

FDA Draft Guidance on Third-Party Review: 3P510k Eligibility Factors | United States

The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party...

FDA Draft Guidance on Real-World Evidence: Considerations for Collection and Analysis | United States

The  article highlights the aspects related to the key considerations for methodologies used in the context of the collection and analysis of real-world evidence. ...

Legislative Oversight? Addressing the High Court Jurisdiction Vacuum Post-IPAB vis-a-vis Cancellation Petitions under the Trademark Act

Recently, the Delhi High Court referred 3 questions regarding the jurisdiction of a High Court to hear trademark rectification applications, to a larger bench....

FDA Draft Guidance on Translation of GLP Study Reports: Overview | United States

The article provides a brief overview of the approach to be followed for the reports related to studies and reports associated with it. ...

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