Regulatory Guidance Monthly Review - October 2020

October 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 October 2020.

 

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New FDA Guidance Documents:

 

Providing Regulatory Submissions In Electronic Format — Standardized Study Data (Published 29Oct2020)

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Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products (Published 28Oct2020)

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Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date (Published 28Oct2020)

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Referencing Approved Drug Products in ANDA Submissions (Published 27Oct2020)

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Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product— Compliance Policies Guidance for Industry (Published 22Oct2020)

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Emergency Use Authorization for Vaccines to Prevent COVID-19 Guidance for Industry (16Oct2020)

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Testing for Biotin Interference in In Vitro Diagnostic Devices (15Oct2020)

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Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (13Oct2020)

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Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment  (Published 01Oct2020)

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Importation of Certain FDA Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (Published 01Oct2020)

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New Draft Guidance Documents:

 

Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry (Published 20Oct2020)

Download DRAFT Guidance

 

Premenopausal Women with Breast Cancer: Developing Drugs for Treatment Guidance for Industry (Published 07Oct2020)

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Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment Guidance for Industry (Published 01Oct2020)

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Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment (Published 01Oct2020)

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Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

FDA, Homeland Security Agencies Take Additional Action to Prevent Import of Illegal and Harmful Medical Products Through International Mail Facilities (Published 30Oct2020)

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EMA outlines regulatory transparency measures amid COVID pandemic (Published 30Oct2020)

Read RAPS Article

 

FDA revises REMS MAPP for new comparable ETASU provisions (Published 30Oct2020)

Read RAPS Article

 

FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order (Published 30Oct2020)

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PDUFA VII: FDA and industry set priorities in first round of negotiations (Published 29Oct2020)

Read RAPS Article

 

Lack of product-specific guidance slows ANDAs: FDA study (Published 29Oct2020)

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EMA rolls out implementation plan to address nitrosamine impurities (Published 28Oct2020)

Read RAPS Article

 

FDA delays enforcement of some DSCSA provisions by three years (Published 26Oct2020)

Read RAPS Article

 

FDA’s COVID-19 vaccine adcomm raises questions as first readouts loom (Published 23Oct2020)

Read RAPS Article

 

Breast implant-lymphoma link probed by EC committee (Published 23Oct2020)

Read RAPS Article

 

EMA highlights multiple considerations when developing drugs for older adults (Published 23Oct2020)

Read RAPS Article

 

FDA Approves First Treatment for COVID-19 (Published 22Oct2020)

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FDA plans master protocols to monitor COVID vaccine safety, efficacy (Published 22Oct2020)

Read RAPS Article

 

Oncology research mid-pandemic: Challenges may bring durable innovation (Published 19Oct2020)

Read RAPS Article

 

CDER launches quality management maturity pilots for APIs and finished dosage forms (Published 16Oct2020)

Read RAPS Article

 

EC lays out strategy for effective COVID vaccine rollout (Published 16Oct2020)

Read RAPS Article

 

FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China (Published 15Oct2020)

Read News Release

 

FDA officials, experts discuss impact of COVID-19 on cell and gene therapies (Published 15Oct2020)

Read RAPS Article

 

FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications (Published 15Oct2020)

Read News Release

 

FDA Approves First Treatment for Ebola Virus (14Oct2020)

Read News Release

 

Testing requirements are likely slowing biosimilar entries in the US (Published 14Oct2020)

Read RAPS Article

 

TGA gives Pfizer COVID vaccine provisional determination (Published 14Oct2020)

Read RAPS Article

 

Study: Few new drugs have high therapeutic value (Published 12Oct2020)

Read RAPS Article

 

TGA moves AstraZeneca's vaccine on first step toward approval (Published 09Oct2020)

Read RAPS Article

 

FDA orphan drug updates at NORD Summit (Published 09Oct2020)

Read RAPS Article

 

Marks sheds more light on COVID-19 vaccine EUA guidance (Published 08Oct2020)

Read RAPS Article

 

FDA updates COVID-19 testing FAQ, will no longer accept EUAs for LDTs (Published 08Oct2020)

Read RAPS Article

 

EMA offers new Q&A on data monitoring committees (Published 08Oct2020)

Read RAPS Article

 

FDA awards six grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases (Published 08Oct2020)

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FDA Reaffirms Commitment to Safety, Security of its Public Health Laboratories (Published 08Oct2020)

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EMA moves to IRIS for scientific advice questions (Published 07Oct2020)

Read RAPS Article

 

CHMP starts rolling review of Pfizer/BioNTech COVID vaccine (Published 06Oct2020)

Read RAPS Article

 

CDER’s NextGen Portal now accepts manufacturing capacity submissions (Published 06Oct2020)

Read RAPS Article

 

FDA announces all-time low rates for FY2021 PRVs (Published 05Oct2020)

Read RAPS Article

 

FDA Approves Drug Combination for Treating Mesothelioma (Published 02Oct2020)

Read News Release

 

FDA releases draft guidance for physiologically based PK analyses (Published 01Oct2020)

Read RAPS Article

 

EMA kicks off rolling review of AstraZeneca COVID vaccine candidate (Published 01Oct2020)

Read RAPS Article

 


 

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