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The Good, Bad, and Ugly side of 510(k)s—HP&M’s Early Experience with the eSTAR Template for 510(k)s

The FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. Several sections of the eSTAR templates have questions that walk through related guidance documents. By Adrienne R. Know Your Guidances.

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The 20 Key Moments in the 340B Program's 30-Year History

Omnicell

2005: HRSA publicly raised alarms against discriminatory reimbursement to 340B providers. The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

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CMC Requirements for New Drug Registration in Latin America

ISPE

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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A New Regulatory Approach to Drive Sustainable Medicines

ISPE

Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” Published November 2005. Press Release. 30 November 2022. link] 6 European Medicines Agency. Committee for Medicinal Products for Human Use. 27 January 2022. link] 13 Beierle, J.,

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Can holograms help in the frontline fight against pharmaceutical counterfeiting?

European Pharmaceutical Review

These include Meditag serialised hologram labels, first introduced in 2005 and found on all registered medicines in Malaysia to help pharmacists and inspectors detect unauthorised and counterfeit product. Several branded medicines are available that feature holograms on the packaging or in the blister pack.”

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