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Jun 30, 2019

Research Investigational New Drug Applications – What You Need To Know
Similarities and differences in submission requirements for Commercial and Research IND

FDA recently released an update to clarify when ‘Research’ vs. ‘Commercial’ should be selected on FDA Form 1571, and thus when electronic common technical document or “eCTD” requirements would apply for an investigational new drug or “IND” application.

An IND is generally considered commercial when the product under investigation is intended to be commercialized at a later date. In this case, the sponsor should select “Commercial IND” on FDA Form 1571 Field 6B.

In comparison, an IND is generally considered research if the product under investigation is not intended to be commercialized at a later date. In this case, the sponsor would select “Research IND” on FDA Form 1571 Field 6B.

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Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
This guidance document is being distributed for comment purposes only.

Over the past few decades, FDA policy initiatives have focused on promoting enrollment practices that lead to clinical trials better reflecting the population most likely to use the drug if the drug is approved, primarily through broadening eligibility criteria. Despite these efforts, challenges to participation in clinical trials remain, and certain groups continue to be 20 unnecessarily underrepresented in many clinical trials. This guidance recommends approaches that sponsors of clinical trials to support a new drug application or a biologics license application can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations in their clinical trials.

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ANDA Submissions — Content and Format of Abbreviated New Drug Applications
Guidance for Industry ensuring a complete, high-quality application submitted to FDA

This guidance is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). This guidance details the information that should be provided in each section of the common technical document (CTD) format for human pharmaceutical product applications and identifies supporting guidance documents and recommendations issued by FDA to assist applicants in preparing their ANDA submission. This guidance identifies the information that an applicant should include to ensure that a complete, high-quality application is submitted to FDA. FDA has previously published guidance documents on the filing process, including the guidance for industry about refuse-to-receive standards, and common, recurring deficiencies which should be reviewed thoroughly prior to submission of an ANDA.

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Optimisation of Safety Data Collection
This guidance is being distributed for comment purposes only

This Guideline is intended to provide internationally harmonised guidance on when it would be appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented. By collecting selective safety data, the burden to patients would be reduced, a larger number of informative clinical studies could be carried out with greater efficiency, studies could be conducted with greater global participation, and the public health would be better served.

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FDA takes new step to help advance the transition of certain biological products
FDA Proposes New Rule on Allowing the Use of DMFs for Transitioning Biologics

The US Food and Drug Administration (FDA) on June 27, 2019 issued a proposed rule to allow certain applications for biological products approved under the Federal, Food, Drug, and Cosmetic Act to continue incorporating by reference information on drug substances, drug substance intermediates, or drug products contained in drug master files (DMF) after the approved applications for those products are deemed to be licenses under the Public Health Service Act (PHS Act) on March 23, 2020.

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One additional country to benefit from EU-US mutual recognition agreement for inspections
Germany Joins EU-US GMP Mutual Recognition Pact

On 26 June 2019, Germany was included into the mutual recognition agreement between the European Union and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of this additional EU Member State to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. The agreement mutually recognizes inspections of manufacturing sites for human medicines conducted in the different territories.

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Guidance Document: Pre-market Requirements for Medical Device Cybersecurity
Health Canada’s new premarket requirements on medical device cybersecurity came into effect

Health Canada’s new premarket requirements on medical device cybersecurity came into effect on 27 June 2019, following the adoption of the regulator’s final guidance document earlier this month.

The final guidance document introduces new information under certain pre- and post-market areas. Most updates address monitoring and responding to emerging risks, as well as license applications, including the Table of Contents (ToC) format. Considerations for monitoring and responding to emerging risks relate to post‐market vigilance, patching, disclosures of vulnerabilities and information sharing.

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China publishes regulation on management of human genetic resources
New rules to regulate genetic research

The State Council, China's cabinet, published a regulation on the management of human genetic resources that will take effect from July 1. The regulation aims to enhance protection of human genetic resources, promote proper use and tighten regulation and supervision, said a State Council statement on 10 June 2019.

Foreign organizations and domestic institutions founded or controlled by foreign entities will have to work with Chinese partners if they need human genetic resources in China for scientific research, the document said.

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