Regulatory Guidance Monthly Review - September 2020

September 2020 


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Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in September 2020.

 

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New FDA Guidance Documents:

 

ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs Guidance for Industry (Published 28Sep2020)

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FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards (Published 21Sep2020)

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Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry (Published 15Sep2020)

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Recognition and Withdrawal of Voluntary Consensus Standards Guidance for Industry and Food and Drug Administration Staff (Published 15Sep2020)

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Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Guidance for Industry (Published 14Sep2020)

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Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency Guidance for Industry (Published 10Sep2020)

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Control of Nitrosamine Impurities in Human Drugs Guidance for Industry (Published 02Sep2020)

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Investigational COVID-19 Convalescent Plasma Guidance for Industry (Published 02Sep2020)

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New Draft Guidance Documents:

 

The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls Guidance for Industry DRAFT GUIDANCE (Published 30Sep2020)

Download DRAFT Guidance

 

E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential—Questions and Answers DRAFT (Published 29Sep2020)

Download DRAFT Guidance

 

Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry DRAFT GUIDANCE (Published 28Sep2020)

Download DRAFT Guidance

 

Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry (Published 15Sep2020)

Download DRAFT Guidance

 

Guidance for Industry Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis, and Impact on Dosing DRAFT GUIDANCE (Published 03Sep2020)

Download DRAFT Guidance


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

Regulation of cell and gene therapy products in China (Published 30Sep2020)

Open RAPS Article

 

HHS seeks drug importation waiver applicants (Published 30Sep2020)

Open RAPS Article

 

Former commissioners call on administration to end FDA criticism (Published 30Sep2020)

Open RAPS Article

 

Hahn insists FDA will stick to guidelines for COVID-19 vaccine decisions (Published 29Sep2020)

Open RAPS Article

 

HHS opens pathway to importing Canadian drugs (Published 25Sep2020)

Open RAPS Article

 

CONSORT-AI sets standards for reporting on artificial intelligence in trials (Published 25Sep2020)

Open RAPS Article

 

EMA addresses use of registry-based studies (Published 24Sep2020)

Open RAPS Article

 

Gene therapies – The regulatory road to individualized medicine (Published 23Sep2020)

Open RAPS Article

 

Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19 (Published 23Sep2020)

View FDA News Release

 

FDA Takes Actions to Help Lower U.S. Prescription Drug Prices (Published 24Sep2020)

View FDA News Release

 

FDA Launches the Digital Health Center of Excellence (Published 22Sep2020)

View FDA News Release

 

WHO: Two-thirds of global population now participating in COVAX initiative (Published 21Sep2020)

Open RAPS Article

 

Euro Roundup: EMA publishes work plan for Big Data Steering Group (Published 17Sep2020)

Open RAPS Article

 

EMA to require clinical data publication for COVID-19 related products (16Sep2020)

Open RAPS Article

 

EU to build biomedical agency, convene health summit, says Von der Leyen (Published 16Sep2020)

View Reuters Article

 

Coronavirus (COVID-19) Update: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests (Published 15Sep2020)

View FDA News Release

 

Marks, Hahn confirm COVID vaccine EUA guidance coming (Published 11Sep2020)

Open RAPS Article

 

Euro Roundup: EU vows to hold COVID vaccine firms liable for side effects (Published 10Sep2020)

Open RAPS Article

 

An overview of upstream manufacturing process and process controls for biologics drug substance: A cytokine case (published 09Sep2020)

Open RAPS Article

 

Pharmacovigilance and QPPV: Post-transition guidance from MHRA (Published 04Sep2020)

Open RAPS Article

 

MHRA: Post-transition guidance on licensing medicines (Published 03Sep2020)

Open RAPS Article

 

EMA finalizes pediatric trial preparedness framework (Published 02Sep2020)

Open RAPS Article

 

EMA, WHO announce updates for steroids in COVID (Published 02Sep2020)

Open RAPS Article

 

U.S. FDA to bring outside experts to review COVID-19 vaccines (Published 02Sep2020)

View Reuters Article

 


 

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