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  • Regulatory NewsRegulatory News

    FDA Updates Orange Book With Patent Submission Dates

    As part of efforts to increase transparency and generic drug competition, the US Food and Drug Administration (FDA) is publishing patent submission dates to help generic drug manufacturers determine the earliest date when they may be able to market new generics. FDA began collecting the patent submission date data in 2013, and the agency says there are about 4,000 patent records for which submission dates are available. The update is the result of a final rule fr...
  • Regulatory NewsRegulatory News

    FDA Revises Priority ANDA Draft Guidance

    The US Food and Drug Administration (FDA) on Friday issued a revised version of its draft guidance on the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA). As part of the negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA II), FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a pre-submission facility correspondence (PFC) at leas...
  • Regulatory NewsRegulatory News

    Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable'

    A generic drug industry group and several companies have taken issue with recent US Food and Drug Administration (FDA) draft guidance on pre-submission facility correspondence (PFC) that spells out what companies need to do to obtain faster abbreviated new drug application (ANDA) reviews. In June, FDA released the draft guidance noting that it is "critical" for there to be a two-month lead time to determine whether facility inspections will be needed for the 8-mon...
  • Regulatory NewsRegulatory News

    EMA Explains Early Industry Engagements Following EU Ombudsman's Questions on Bias

    Following an inquiry into the perception of bias in early interactions between the biopharma industry and the European Medicines Agency (EMA), EMA executive director Guido Rasi tried to assure the EU ombudsman that the risk of bias is manageable. "While we acknowledge the need to avoid and manage any risk of bias, experience over the years shows that such risk can be managed by having in place the necessary safeguards and I can assure you that the Agency guarantees...
  • Regulatory NewsRegulatory News

    FDA to Revise Pre-Submission Draft Guidance Due to GDUFA II

    Now that the FDA Reauthorization Act of 2017 (FDARA) is law, the US Food and Drug Administration (FDA) said Tuesday it will revise previously issued draft guidance on the pre-submission of certain information for abbreviated new drug applications (ANDAs). FDARA, which was signed by President Donald Trump last Friday , includes statutory provisions that will expedite the review of qualifying ANDAs by allowing the “pre-submission” of certain information prior to s...
  • Regulatory NewsRegulatory News

    Priority Generic Drug Reviews: New FDA Draft Guidance

    In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II) , the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs. Under GDUFA II, FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a complete and accurate pre-submission facility correspondence (PFC) two months ahead of their a...
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    FDA Draft Guidance Looks to Help Speed New Generics to Market

    The blitz of new US Food and Drug Administration (FDA) guidance (11 draft and final documents in the last three days) continued on Friday with the release of a draft helping to clarify for generic drug companies how to define and use several terms, and new ways to expedite generic approvals. In a shift in direction for the agency, and in order to speed the availability of generics, FDA “now will approve a generic drug for which it has made a final determination that the ...
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    Impurity Deficiencies: How FDA Can Refuse-to-Receive an ANDA

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance that will assist abbreviated new drug application (ANDA) submitters seeking approval of a new strength of a drug. The guidance, for applicants preparing to submit to FDA ANDAs and prior approval supplements to ANDAs, highlights serious deficiencies in impurity information that may cause FDA to refuse-to-receive (RTR) an ANDA. Specifically, FDA says the deficiencies include: “(1) Failing to provi...
  • Feature ArticlesFeature Articles

    Strategic Regulatory Considerations for Early Medical Device Consultations with Global Regulatory Authorities

    This article discusses the early consultation process for medical devices in the EU and US and key considerations when planning such a meeting. Developing a Global Strategy for Early Consultations Are you developing an innovative medical device? Does it employ a novel technology? Does it provide novel diagnostic information or therapeutic benefit? Is it a combination or borderline product or a companion diagnostic? Do your plans to demonstrate safety, performance and/...
  • Feature ArticlesFeature Articles

    Integrating FDA Meetings into a Medical Device Regulatory Strategy

    This article focuses on the strategic use and suitability of a Q-Submission program. Introduction An often overlooked opportunity for a successful device regulatory strategy is the optimal use of a pre-submission meeting with the regulatory agency. Meeting with the US Food and Drug Administration (FDA) to request feedback on specific submission issues has been formalized into what is collectively called the Q-Submission (Q-Sub) Program. A detailed description of the...
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    Facilities Sterilizing Devices via 'Novel' Methods Will See New FDA Inspections

    As medical devices are sterilized with novel and sometimes risky new methods and chemical combinations, the US Food and Drug Administration (FDA) announced Wednesday that it will begin inspecting companies' manufacturing facilities before clearing their 510(k) applications. The shift in FDA’s thinking comes as the agency says in Wednesday’s final guidance, issued more than seven years after the draft document was released, that it’s received “an increasing number of 510(...
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    Book Review: The FDA Clinical Submission Survival Manual

    A regulatory professional's primary role is communication with FDA, other regulatory agencies and internal stakeholders in the written and oral form. The quality of a regulatory professional's communication skills can make or break a company. " The FDA Clinical Submission Survival Manual " contains useful tips and processes to improve FDA communication. It contains specifics on how to plan, develop and test strategy and key messages for a marketing application, with a fo...