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US FDA prescribes situations for black box warning

Dr Arun Bhatt
Wednesday, February 5, 2020, 08:00 Hrs  [IST]

Is there any checklist that want submission of permission of patent owner for research on herbal extract or herbal medicine?

Dr Shyam Advani

Please consider following information, which may be relevant to herbal patent (ref: http://www.ipindia.nic.in)

Invention not patentable
Invention, whose commercial exploitation contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;
Plants and animals (other than microorganisms) but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals;
Method of agriculture or horticulture
Traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components. It is available the details of patent submission process on the website of Indian patent office.

Is there any guideline or criteria for authorship when multi-centric clinical trial is conducted?
Dr Deepak Bhatia

ICMR 2017 guidelines recommend that the researchers should follow the guidance of International Committee of Medical Journal Editors (ICMJE) on authorship. This is largely accepted as a standard and is endorsed by the World Association of Medical Editors (WAME).
According to the ICMJE, authorship entails the following criteria:
  • Substantial contributions to the conception or design of the work, or the acquisition, analysis, or interpretation of data for the work;
  • Drafting the work or revising it for important intellectual content;
  • Final approval of the version to be published;
  • Agreement to be accountable for all aspects of the work and ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Institutions and departments should have authorship policies. The primary author should be the person who has done most of the research work related to the manuscript being submitted for publication. Research performed as part of a mandatory requirement of a course/fellowship/training programme including student research should have the candidate as the primary author. All efforts must be made to provide the candidate with an opportunity to fulfil the second, third and fourth criteria of the ICMJE guidelines.

If the clinical trial is multi-centric, the sponsor describes the policy of authorship in the investigator agreement.

What are criteria for black box warning?
Dr Sunita Amin

US FDA prescribes following situations for black box warning. When to use a boxed warning for prescribers one of the following situations is required: There should be an adverse reaction so serious in proportion to the potential benefit from (e.g., a fatal, life-threatening or permanently disabling adverse reaction) that it is essential that it should be considered in assessing the risks and benefits of using the drug; or there is a serious adverse reaction that can be prevented or reduced in severity by appropriate use of the drug (e.g., patient selection, careful monitoring, avoid certain concomitant therapy, addition of another drug or managing patients in a specific manner, avoiding use in a specific clinical situation); or FDA approved the drug with restrictions to ensure safe use because the drug can be safely used only if distribution or use is restricted.

Can we get a list of blacklisted investigators and reason from CDSCO?
Dr Mina Desai

CDSCO website does not display details of regulatory inspection findings or letters. However, US FDA lists inspection findings for all Indian sites inspected – https://www.fda.gov/drugs/drug-approvals-and-databases/clinical-investigator-inspection-list-cliil. u

Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com


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Abhishek Sharma Feb 17, 2020 11:27 AM

we have a site in Ahmedabad and now site wants to add another site (branch of hospital) as satelite site which is located in Mumbai.
is it possible or if possible what documentation is required ?
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