• Draft Guidance Increases FDA Flexibility During Interactive Reviews of Medical Device Submissions

    The US Food and Drug Administration (FDA) has released a new draft guidance for industry intended to clarify the types of communication used during the review of medical device product submissions made to its Centers for Devices and Radiological Health (CDRH) and Biological Evaluation and Research (CBER). Background The draft guidance is intended to reflect changes undertaken by the agency under two pieces of legislation critical to FDA's mission: the Medical Device Us...
  • MHRA Advocates Use of Online Submissions Platform by Applicants

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is "strongly" encouraging all applicants to participate in its pilot participation in the Central European Submissions Platform (CESP), an online-based secure submissions system. Currently, applicants are permitted to submit applications to MHRA using data contained on CDs or DVDs, depending on the size of the submission. However, this submission style necessitates manual handing of media, storage spac...
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    Demystifying the FDA Appeals Process

    For more than a decade, there has been confusion about the appeals process at the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). There are several avenues to file an appeal, each with specific requirements. This article aims to clarify the CDRH appeals process so stakeholders can use it effectively. The relevant processes for FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research ...
  • New 510(k) Guidance Consolidates Pre-Review Policies

    A new draft guidance document published by the US Food and Drug Administration (FDA) establishes the criteria under which the agency can refuse to accept a 510(k) substantial equivalence application submitted to the agency. 510(k) applications are used to approve devices which are based upon and otherwise substantially equivalent to medical devices approved by FDA. Under the 510(k) process, devices are cleared-not approved-by the agency if they can show substantial equiv...
  • EMA Releases Updated Final Guideline on Active Substance Master Files

    A new final guideline published on 13 July 2012 by the European medicines Agency (EMA) updated the Active Substance Master File (ASMF) Procedure -its first upgrade since its formation in 2006. The ASMF procedure, formerly known as the European Drug Master File (EDMF) procedure, is used to protect confidential intellectual property information while allowing regulatory agencies to access a more complete picture regarding how an active substance is manufactured. Both EMA a...
  • Final FDA Rule Sets Application Requirements for Manufacturers of Pacemakers

    Manufacturers of implantable pacemaker pulse generators and the devices that program them are receiving a final rule from the US Food and Drug Administration (FDA) today informing them of new application filing requirements coming into effect in September 2012. In two separate 22 June Federal Register postings, FDA said manufacturers of pacemaker devices and pacemaker programmers will now be required to file a premarket approval application (PMA) or a complete product ...
  • NICE Unveils Mobile Prescribing App to Keep Healthcare Professionals Up-to-date

    Physicians could soon be dispensing more accurate and up-to-date prescriptions in Britain thanks to a new mobile medical application from the British National Formulary (BNF) and the National Institute for Health and Clinical Excellence (NICE). The organizations announced on 13 June the launch of a new application capable of running on both Apple's iOS and Google's Android operating systems which comprise much of the mobile phone market across the world. In a statement,...
  • Minor Changes Planned For User Fee Application Forms

    • 17 May 2012
    The cover sheet used by pharmaceutical and biotechnology companies when submitting their user fees scheduled to receive an upgrade, the US Food and Drug Administration (FDA) revealed in a Federal Register posting. The sheets are currently mandatory for companies, which pay the agency fees in return for having their applications reviewed under the terms of the Prescription Drug User Fee Act (PDUFA) . "Because the submission of user fees concurrently with applications a...
  • EMA Issues Guidance for Companies Seeking Scientific Advice

    The European Medicines Agency (EMA) has released revised guidance to answer questions about the process of seeking scientific advice from the agency, including an overview of the scientific advice process and how to prepare a request for scientific advice. EMA's Guidance for Companies Requesting Scientific Advice , the third revision of which was released on 15 May 2012, covers pre-submission meetings where companies request guidance from EMA staff on scientific issue...
  • Bill Introduced to Speed Development and Review of Breakthrough Therapies

    A bipartisan bill introduced in the House of Representatives would work to speed up the development and review of some drugs intended to treat life-threatening diseases by creating a new "breakthrough therapy" designation at the US Food and Drug Administration (FDA). The bill, To amend chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to expedite the development and review of breakthrough therapies , would amend the FD&C Act  to include pr...
  • 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 ...
  • CDRH Releases New Training Module for Guidance on Benefit-Risk Determinations

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released a new training module on a guidance document released by the agency that focuses on making benefit-risk determinations for medical device submissions. FDA's guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications , was released 27 March 2012. FDA noted at the time of the guidance release ...