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  • Regulatory NewsRegulatory News

    Meeting With FDA After a CRL: Draft Guidance on What to Expect

    The US Food and Drug Administration (FDA) on Friday released new draft guidance for industry on the 30-minute post-complete response letter (CRL) meetings between FDA and abbreviated new drug application (ANDA) applicants to help clarify deficiencies. The guidance, released as part of the agency's second Generic Drug User Fee Amendments (GDUFA II) commitments, offers details for companies on what a meeting request should include, how the requests will be assessed, ...
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    PDUFA VI: FDA Explains User Fee Changes in Draft Guidance

    The US Food and Drug Administration (FDA) has begun implementing the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and on Thursday released draft guidance explaining the new fee structure and types of fees for which industry is responsible. Changes to the fee structure under PDUFA VI mean FDA can collect two types of fees through 2022: human drug application fees (accounting for 20% of the total), collected at the time applications are submitted, and pres...
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    When to Submit an ANDA vs. a 505(b)(2) Application: FDA Discusses in Draft Guidance

    The US Food and Drug Administration (FDA) offers multiple abbreviated approval pathways for potential drug developers, and in new draft guidance released on Thursday the agency explains both the pathways where abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted. The draft highlights criteria for submitting ANDAs under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), petitioned ANDAs under section 505(j)(2)(C) ...
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    REMS Format and Content: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics. The 34-page draft revises 2009 draft guidance for industry known as, "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications." FDA notes at the outs...
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    Boehringer Questions FDA's Draft Guidance on Optional Child-Resistant Packaging Statements

    Boehringer Ingelheim has questions on how new US Food and Drug Administration (FDA) draft guidance on optional child-resistant packaging (CRP) statements will benefit health care professionals and consumers. The draft guidance , released 2 August, offers help for drugmakers looking to use the statements and ensure they are clear, useful, informative and, to the extent possible, consistent in content and format. Boehringer, however, questions "whether thi...
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    FDA Targets Complex Generic Drugs With New Draft Guidance

    The US Food and Drug Administration (FDA) on Monday kicked off a two-day meeting on modernizing generic drug development and released two new draft guidance documents on complex generic drugs – an area where increasing competition can be difficult. FDA Commissioner Scott Gottlieb spoke at the meeting on Monday morning, highlighting recent moves to establish a list of off-patent drugs that will receive expedited approval if an abbreviated new drug application (AND...
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    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...
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    FDA Offers Draft Guidance on Organ Preservation Device Animal Studies

    As the national organ transplant waiting list continues to grow and donation and transplant rates remain stagnant, the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help industry with recommendations on best practices for animal studies used to evaluate organ preservation devices. Background The shortage of organs available for transplants has propelled a new wave of organ preservation technologies, FDA says, noting that these te...
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    FDA Steps in to Regulate Microneedling Devices

    The US Food and Drug Administration (FDA) on Thursday issued a draft guidance detailing when it considers "microneedling" products to be medical devices and subject to regulation. In recent years microneedling has emerged as a trendy cosmetic procedure often advertised as a minimally invasive option for treating scars, wrinkles, acne and stretch marks, and is often performed at home or at plastic surgery centers. A quick Google search reveals product listings for mech...
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    Nonclinical Recommendations for Radiopharmaceuticals: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Tuesday released draft guidance on nonclinical study recommendations for microdose radiopharmaceutical diagnostic drugs. The 7-page draft seeks to help developers of these microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing authorization. The draft specifically discusses how to refine nonclinical study recommendations for this class of dru...
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    FDA Aligns With Citizen Petition, Revises Draft Guidance on Pricey Generic Heart Drug

    Manufacturers looking to market generic versions of a heart medicine that has been around since the 18th century and seen its price rise by more than 600% in recent years will have to work with a new revised US Food and Drug Administration (FDA) draft guidance released Tuesday. The revised guidance aligns with a citizen petition filed by Concordia Pharmaceuticals , the manufacturer of the authorized generic version of the drug, known as digoxin (or by t...
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    FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics

    As the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report. "Under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities, o...