• Regulatory NewsRegulatory News

    New MAPP details when FDA notifies drugmakers about ARIA studies

    In a new manual of policies and procedures (MAPP) released on Monday, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) explains how and when it will notify applicants when the agency plans to study a product using its Sentinel active risk identification and analysis (ARIA) system.   Before FDA can require a postmarketing study or clinical trial for a drug, it must determine whether its ARIA system or adverse event reporting sys...
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    FDA Targets Multiple Review Cycles With New Draft Guidance, MAPP

    Fresh out of a record year for generic drug approvals, the US Food and Drug Administration (FDA) on Wednesday kicked off the new year by releasing new draft guidance and a new manual of policies and procedures (MAPP) with an eye toward decreasing the number of review cycles abbreviated new drug applications (ANDAs) undergo before approval. Multiple review cycles has been an outstanding challenge for the agency in years past, with less than 10% of ANDAs winning ap...
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    Gottlieb: FDA to Issue new Policies to Streamline Generic Reviews in 2017

    By the end of 2017, the US Food and Drug Administration (FDA) will issue two new documents to improve the review process for generic drugs, according to FDA Commissioner Scott Gottlieb. Gottlieb made the announcement at a public hearing looking into barriers to generic drug competition held at FDA's campus in Silver Spring, MD on Tuesday. While the hearing focused on gathering input from the public and industry issues such as risk evaluation and mitigation strategies ...
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    Think Tank Seeks Ebola Info from FDA, Calling it a Test Case for Compassionate Use System

    A libertarian-leaning think tank is pressuring the US Food and Drug Administration (FDA) to release information regarding the internal approval processes it used to permit two US citizens stricken with Ebola access to Mapp Biopharmaceuticals' ZMapp, an experimental drug. Background In August 2014, the American public became fixated on an outbreak of Ebola in West Africa after two US missionaries, Dr. Kent Brantley and Nancy Writebol, became infected with the disease. In...
  • New FDA Policy Updates, Clarifies Process of Moving to Electronic Submission Forms

    The US Food and Drug Administration (FDA) has released a new manual of policies and procedures (MAPP) for its internal drug regulatory staff regarding the creation and maintenance of its electronic submissions docket, the system that dictates how pharmaceutical and biotechnology companies submit applications to the agency. The MAPP, Maintaining CDER's Electronic Submissions Docket , regards the more practical aspects of 21 CFR 11, which permits the Center for Drug E...
  • FDA Now Able to Temporarily Approve Generic Drugs Using Different Label than RLD

    The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), part of its Center for Drug Evaluation and Research (CDER), is out with the new policy that aims to clarify how its staff should implement a relatively new statutory provision that permits the agency to approve generic drugs even when labeling changes are happening with  its comparator product, the reference listed drug (RLD). Background The section in question, 505(j)(10) of the Federal Fo...
  • New FDA Staff Policy Manual Defines 'Major Amendments' to Generic Drug Submissions

    The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD) has released a new guideline for its internal review staff on how to handle amendments to generic drug applications. The Manual of Policies and Procedures (MAPP), Reviewer Determination of Major/Minor Amendments to Abbreviated New Drug Applications , is specifically intended for OGD's chemistry review staff. After submitting an original or supplemental Abbreviated New Drug Application (ANDA), ...
  • Revised FDA Manual Provides Statistical Reviewers with Standardized Template

    A revised Manual of Policies and Procedures (MAPP) developed for US Food and Drug Administration (FDA) drug review staff instructs them on how to assess statistical reviews using good review practices (GRPs) using a standardized review template. The MAPP, Good Review Practice: Statistical Review Template , specifically applies to employees within the Center for Drug Evaluation and Research's (CDER) Office of Translational Sciences (OTS)-an office charged with promot...
  • CDER Provides Guidance to FDA Staff on How to Expedite Review of ANDA Supplements

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has issued a new Manual of Policies and Procedures (MAPP) document in which the agency describes to internal staff the guidelines for expediting the review of Abbreviated New Drug Application (ANDA) supplements. FDA's 5240.1: Requests for Expedited Review of Supplements to Approved ANDAs , posted  27 April, describes how ANDA supplement sponsors "may ask FDA to expedite ...
  • Owe FDA Money? Don't Bother Submitting an Application, Says CDER

    A new Manual of Policies and Procedures (MAPP) document issued by the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) notes that if a pharmaceutical manufacturer is in arrears to FDA, CDER "shall refuse to accept the application for filing." FDA's MAPP 60.50.1 Rev. 1, Refusal to Accept Applications for Filing From Applicants in Arrears , notes "It is the general policy of CDER that human drug applications and supplements will be ...
  • FDA Seeks to Standardize CDER's Telephone Availability

    A new manual of policies and procedures (MAPP) released by the US Food and Drug Administration's (FDA) Office of Management (OoM) dictates how the Center for Drug Evaluation and Research (CDER) must maintain adequate and consistent phone coverage to allow regulatory professionals and the public to reach the agency during normal business hours. "As Federal employees and public servants, CDER employees must be responsive to the needs of the public," writes OoM. "The public...
  • FDA Revises MAPP for Regulatory Project Management Site Tours

    A newly-revised manual of policies and procedures (MAPP) document released by the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research outlines the policies and procedures for selecting pharmaceutical companies for participation in FDA's Site Tours Program (STP) and how FDA oversees the program. FDA uses the Site Tours Program to experience the drug development process from an industry perspective, share regulatory project management informatio...