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The Beginner’s Guide to Mobile Healthcare Applications

Viseven

Digital health app providers added over 90,000 new apps to app stores in 2020. Mobile apps can help healthcare workers remember their daily tasks, browse the documentation, and optimize communication within their teams. Remote communications. Apps for Clinical Communications. billion in 2021. Patient Loyalty.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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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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Can holograms help in the frontline fight against pharmaceutical counterfeiting?

European Pharmaceutical Review

Indeed, a 2020 operation coordinated by Europol across 27 countries led to the seizure of more than 25 million units of counterfeit anticancer drugs and erectile dysfunction medicines among other fake drugs worth nearly €73 million. Several branded medicines are available that feature holograms on the packaging or in the blister pack.”

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Please check your email to download the Report.

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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

In addition to the FDA, health authorities in Canada, Europe, Australia, Japan, Switzerland, and New Zealand have also approved applications with CM for the production of solid oral dosage forms. End-to-end continuous processes flow from starting materials to finished dosage forms. Updated 19 April 2016. 4 a b Byrn, S., Jayjock, N.

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