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Jul 15, 2019

Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent
Pregnancy Guidance for Industry

This draft guidance document is being distributed for comment purposes only.

This guidance provides recommendations for clinical trials designed to establish clinical effectiveness and safety for hormonal drug products intended to prevent pregnancy. Drug product development in hormonal contraception has evolved over the years, especially with the development of lower-dose hormonal drug products and longer-acting reversible contraceptives. Changes in patient demographics, pregnancy testing, determinations of conception date, and dosing directions have also occurred. This guidance reflects these developments and is generally consistent with advice we have been providing to individual sponsors developing hormonal drug products.

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Pharmacokinetics Guidance for Industry

This draft guidance document is being distributed for comment purposes only.

This guidance is intended to assist sponsors of new drug applications (NDAs) and biologics license applications (BLAs) in the application of population pharmacokinetic (population PK) analysis. Population PK analysis is frequently used to guide drug development and inform recommendations on therapeutic individualization (e.g., through tailored dosing). Adequate population PK data collection and analyses submitted in marketing applications have in some cases alleviated the need for postmarketing requirements (PMRs) or postmarketing commitments (PMCs).

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Risk Evaluation and Mitigation Strategies:
Modifications and Revisions Guidance for Industry

The availability of a final guidance updated from the guidance of the same name, issued April 7, 2015

The Food and Drug Administration (FDA or Agency) announced the availability of a final guidance for industry entitled “Risk Evaluation and Mitigation Strategies: Modifications and Revisions” on July 10, 2019. This guidance provides information on how FDA will define and process submissions for modifications and revisions of risk evaluation and mitigation strategies (REMS), as well as information on what types of changes to approved REMS will be considered modifications or revisions of the REMS. The guidance also provides instructions to application holders related to procedures for submission of REMS modifications and revisions to FDA as well as different timeframes for FDA's review of and action on such changes. The definitions of REMS modifications and revisions apply to all types of REMS. This guidance updates the guidance of the same name, issued April 7, 2015, including finalizing the portion that sets forth the submission procedures for REMS revisions.

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Regulations on Customized Medical Device Supervision and Management (Trial Version) in China
New regulations on customized medical devices in China

On July 4th, the National Medical Products Administration (NMPA) issued “customized medical device supervision and management regulations (Trial Version) (NMPA order No. 53 2019)” implemented from January 1st, 2020. The target of the regulations is to meet the clinical personalized demands and ensure the effectiveness and safety of customized medical devices.

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Why Industry Anticipates a ‘Cliff-Edge’ Scenario with EU MDR/IVDR
Manufacturers and the European Association of Notified Bodies alike face difficult decisions with the new

EU’s medical device and in vitro diagnostic regulations (MDR/IVDR)

The EU's medical device and in vitro diagnostic regulations (MDR/IVDR) may cause a "cliff-edge scenario," meaning a disruption in the supply of certain medical devices and IVDs, industry groups and the European Commission (EC) recently cautioned.

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German Study Finds Most New Drugs Fail to Improve on Standard of Care
Germany’s Institute of Quality and Efficiency in Healthcare (IQWiG) finds there is no evidence of added benefit for more than half of the drugs the institute assessed from 2011-2017.

In Germany, IQWiG is charged with assessing new drugs to determine their added benefit compared to the standard of care on behalf of the Federal Joint Committee (G-BA), the main decision-making body for the country’s national health insurance system. The requirement for all newly approved drugs to undergo a benefit assessment stems from the 2010 Act on the Reform of the Market for Medicinal Products (AMNOG), which went into effect in 2011. The outcome of the benefit assessment is a major factor in the price negotiations that follow between health insurance authorities and drugmakers.

“In general, a new drug with no added benefit should not cost more than standard care,” the authors write.

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