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Aug 17, 2020

Civil Money Penalties Relating to the Data Bank
On 12 August 2020 the FDA announced the availability of the guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff.

This guidance document is intended to describe the current thinking of FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) (hereafter, “Center” or collectively, “the Centers”), regarding civil money penalties under section 303(f)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). That section authorizes FDA to assess civil money penalties against responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products (hereafter, “submitters”) who violate applicable FD&C Act prohibitions relating to requirements under section 402(j) of the Public Health Service Act (PHS Act), including its implementing regulations in 42 CFR part 11, to submit clinical trial registration and/or results information to the data bank and/or certain certifications to FDA.

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Male Breast Cancer: Developing Drugs for Treatment
On 12 August 2020 the FDA announced the availability of the guidance for industry.

This guidance provides recommendations to sponsors regarding the development and labeling of cancer drugs, including biological products, regulated by CDER and CBER for the treatment of male patients with breast cancer.

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Drug-Drug Interaction Assessment for Therapeutic Proteins
On 12 August 2020 the FDA announced the availability of the draft guidance for industry.

The purpose of this guidance is to help sponsors of investigational new drug applications (INDs) and applicants of biologic license applications (BLAs) determine the need for drug-drug interaction (DDI) studies for a therapeutic protein (TP) by providing a systematic, risk-based approach.

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MHRA’s Expectations for Return to UK On-site Inspections
On 11 August 2020 the MHRA published the guidance for industry on planning to resume on-site UK risk-based GxP inspections in September.

In line with a reduction in restrictions, the inspectorate plans to resume an on-site UK risk-based GxP inspection programme starting in September, scaling up to a full programme beginning in October 2020. This programme will use a combination of remote and on-site inspection approaches as COVID-19 restrictions are eased. The MHRA is committed to working with industry to reduce regulatory burdens during the COVID-19 pandemic wherever possible, including flexible approaches to inspection, but this does not diminish or impede the agency’s regulatory powers to inspect.

This guidance describes the points to consider for on-site inspections as the UK Government updates the pandemic restrictions. This will allow the MHRA to fulfil their public health duties, while following the current government guidelines and ensuring all personnel are safe.

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EMA Updated Post-Authorisation Safety Studies (PASS)
On 10 August 2020 the EMA updated post-authorisation safety studies.

The purpose of the information in PASSs is to evaluate the safety and benefit-risk profile of a medicine and support regulatory decision-making. They aim to:

  • identify, characterise or quantify a safety hazard;
  • confirm the safety profile of a medicine, or;
  • measure the effectiveness of risk-management measures.

The EMA has updated the section of questions and answers for non-interventional imposed PASS: Revision to Q&A (#2) and a new Q&A (#16).

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Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format
On 10 August 2020 the FDA announced the availability of the final guidance for industry.

This guidance is intended to assist holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) approved under section 505(c) and 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(c) and (j)), respectively, with submission of marketing status notifications required under section 506I of the FD&C Act (21 U.S.C. 356i). This guidance identifies the required content for these marketing status notifications and the format by which these notifications should be submitted to the Agency.

FDA regulations require NDA and ANDA holders to notify the Agency of the marketing status of drug products approved under NDAs and ANDAs. The FDA Reauthorization Act of 2017 (FDARA) added section 506I to the FD&C Act, which imposes additional marketing status reporting requirements as follows:

  • Notification of withdrawal from sale — requires NDA and ANDA holders to provide a written notification to FDA 180 days prior to withdrawing an approved drug from sale.
  • Notification of drug not available for sale — requires NDA and ANDA holders to provide a written notification to FDA within 180 days of the date of approval of a drug if that drug will not be available for sale within 180 days of the date of approval.
  • One-time report on marketing status — requires NDA and ANDA holders to provide a written notification to FDA within 180 days of enactment of FDARA stating whether the NDA and ANDA holder’s drug(s) in the active section of the Orange Book were available for sale or if one or more of the NDA or ANDA holder’s drugs in the active section had been withdrawn from sale or had never been available for sale.

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MHRA Regulatory Flexibilities Resulting from Coronavirus (COVID19)
On 4 August 2020 the UK MHRA updated the guidance for industry on flexible approaches to regulations taken during the COVID-19 outbreak.

Regulatory flexibilities do not displace or diminish any other obligations applicable to the relevant products. Any medicinal product which benefits from these regulatory flexibilities remains subject to marketing authorisation.

These regulatory flexibilities are:

  • temporary and will be kept under review
  • offered to protect people’s health in exceptional circumstances
  • effective immediately

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