Two Final Guidance Documents on Electronic Submissions Released by the FDA

The introduction and acceptance of electronic submissions as the preferred submission process has been adopted at varying rates by different jurisdictions within the three ICH regions over the past several years. This move to provide a harmonized format has Continue reading

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FDA Publishes Pregnancy and Lactation Labeling Final Rule (PLLR)

The Pregnancy and Lactation Labeling Rule, formally known as the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling (PLLR) has been published by the FDA.

The PLLR has been put into place in order to assist health care providers in Continue reading

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EMA releases finalized guideline on facilitating global development of Biosimilars

The EMA has released a new finalized guideline called Similar Biological Medicinal Products which introduces the main concept of the “possibility for drug product developers to use comparators authorized outside the European Economic Area (EEA)” during clinical development of biosimilars.

The new guidance Continue reading

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Happy Holidays – Year in Review

Happy Holidays to our clients, friends, and family – wishing you a safe and enjoyable winter season.

As we welcome in the holidays we say goodbye to a phenomenal year that saw Regxia go through several pivotal changes that have allowed us to grow and strengthen our commitment to serve our clients.

This past year, we Continue reading

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ClinicalTrials.gov Updated – Proposed Rule would have Clinical Trial Results Reported, even when Product isn’t Approved

The US Department of Health and Human Services Department (DHHS) proposed a new rule with respect to Clinical Trial Registration and Results Submission. This proposed rule Continue reading

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Learn@Regxia’s clients speak, “This webinar really solidified my previous knowledge of GCP…”

November 7, 2014. Another client has completed Learn@Regxia’s ICH GCP online training webinar, and we have received more great feedback! Continue reading

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New Electronic Formatting Requirements for Class III and Class IV MDL Applications

As part of Health Canada’s “ongoing efficiency measures and efforts to reduce regulatory burden on industry and transition to an electronic environment, … [Health Canada announced Continue reading

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FDA Clarifies Tool for Expediting Drug Development; Issues draft guidance for Critical Path Innovation Meetings – Guidance for Industry

14.11.19On October 08, 2014, the FDA issued a draft guidance for industry entitled “Critical Path Innovation Meetings.” The Critical Path Innovation Meetings (CPIM) provides an opportunity for FDA’s Center for Drug Evaluation and Research (CDER) to discuss Continue reading

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The FDA Releases New Guidance Document to Strengthen Cybersecurity of Medical Devices

The US FDA has released a final guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices to strengthen the safety of medical devices.

Although medical devices have the ability to improve patient care and create efficiencies in the healthcare system as they become more interconnected and interoperable, risks for Continue reading

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FDA Draft Guidances: ANDA Submissions – Refuse to Receive for Lack of Proper Justification of Impurity Limits & Refuse-to-Receive Standards

14.11.06FDA has released two draft guidance documents on refuse to receive ANDA submissions. The purpose of the guidances are to help applicants prepare “ANDAs and PASs to ANDAs for which the applicant is seeking Continue reading

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