2005 Communication Documentation 
The FDA Law Blog
FEBRUARY 28, 2023
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.
European Pharmaceutical Review
NOVEMBER 24, 2022
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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European Pharmaceutical Review
DECEMBER 19, 2023
7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Maillard Reaction and Drug Stability. Woodhead Publishing.
Omnicell
JANUARY 10, 2023
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.
ISPE
MARCH 29, 2023
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
ISPE
MARCH 29, 2023
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
ISPE
MAY 9, 2023
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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