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    FDA Drafts Guidance on Inspections of Medical Device Establishments

    The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments. FDA has updated processes and standards for uniformity within and across inspections other than for-cause and to establish a standard timeframe for such inspections of device establishments. The uniformity in FDA investigators’ approaches to these inspections “may inform firms’...
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    FDA Finalizes Guidance on Pediatric Information in Drug Labels

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on the content and placement of pediatric information within the labeling of drugs and biologics.   “The goal of this guidance is to provide recommendations to help ensure that information on the use of prescription drugs in pediatric populations (whether positive, negative, or inconclusive) is consistently placed in the proper sections and subsections within labeling so that the information is c...
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    FDA Draft Guidance on Patient Experience Data Incomplete, Critics Argue

    Industry group BIO, the National Association for Rare Disorders (NORD) and the National Center for Health Research (NCHR) called for clarification on how regulators will use draft guidances proposed by external stakeholders on patient experience data. The comments on the US Food and Drug Administration (FDA) draft guidance from December 2018 on developing and submitting proposed draft guidances related to patient experience data showed some consensus around including ...
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    FDA Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on the nonclinical studies drugmakers should conduct when developing products to treat severely debilitating or life-threatening hematologic disorders (SDLTHDs).   FDA classifies SDLTHDs as hematologic conditions that cause shorter life expectancy or greatly diminished quality of life even with available treatments.   FDA notes that the guidance does not apply to hematologic cancers and covers...
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    CDER Guidance Agenda for 2019: What’s Coming

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to issue almost 100 new draft and revised draft guidance documents spanning 15 different categories, from biosimilars to clinical pharmacology to drug safety, in 2019. The bulk of the guidance documents are contained in three categories: clinical/medical, pharmaceutical quality/CMC and procedural. The guidance in clinical/medical focuses on specific types of develop...
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    Senators Seek Changes to FDA Guidance to Speed Entry of Insulin Biosimilars

    As Eli Lilly announced Monday that it would introduce an authorized generic version of its Humalog insulin at half the original price, four senators on both sides of the aisle are seeking tweaks to recent US Food and Drug Administration (FDA) guidance to speed up the marketing of new biosimilar insulin products. The guidance is part of FDA’s work to begin, starting in March 2020, transitioning approved marketing applications for a subset of products, including insulin...
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    Continuous Manufacturing: FDA Drafts Quality Guidance

    The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out quality considerations for continuous manufacturing (CM) for new and generic drugs.   The 27-page draft guidance is part of FDA’s effort to encourage the adoption of continuous manufacturing and covers quality considerations for solid oral small molecule drugs and builds on feedback from a public consultation launched in 2017.   According to FDA Commissioner Scott Gottlieb and C...
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    Generic Drugs: FDA Releases 74 Product-Specific Guidances

    As part of its push to increase generic competition, the US Food and Drug Administration (FDA) on Friday published 74 product-specific guidances, including 22 new and 52 revised guidances.   Four of the new draft guidances and 45 of the revised guidances are for complex drug products, including 16 products for which there are currently no approved abbreviated new drug applications (ANDAs).   Among the new product-specific guidances is help for companies looking to ...
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    CDRH Issues Guidance on Brain-computer Interface Devices

    Brain-computer interface (BCI) devices for patients with paralysis or amputation snagged the first leapfrog guidance from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) of the year, with new draft nonclinical and clinical recommendations. CDRH released the 42-page draft guidance document on Friday to provide new recommendations on Q-submissions and investigational device exemptions (IDEs) of implanted BCI devices for patien...
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    FDA Offers Guidance on Nicotine Replacement Therapies

    The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations to drugmakers looking to develop nicotine replacement therapy (NRT) products to help patients quit smoking.   The 19-page draft guidance comes after FDA held a public consultation on its approach to evaluating NRT products in November 2017 and a public hearing on the matter in January 2018.   FDA says the draft guidance “takes into consideration the feedback re...
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    CBER Guidance on Gene Therapies: What to Expect in 2019

    The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) on Wednesday released plans for what guidance is to be expected in 2019, including six final guidance documents related to gene therapies. The gene therapy guidance documents ( draft versions were published in July ) the agency expects to finalize include: Long Term Follow-Up After Administration of Human Gene Therapy Products; Guidance for Industry Chemistry, Manufacturing, an...
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    FDA Draft Guidance on Broader Labeling for Oncology Companion Diagnostics Draws Mixed Reactions

    Developers of companion diagnostic (CDx) tests as well as pharmaceutical and biotechnology groups and companies expressed mixed reactions to the US Food and Drug Administration (FDA) draft guidance on broader labeling of in vitro CDx assays for a specific group or class of oncology therapeutic products. The support and concerns were expressed through comments recently submitted to FDA’s draft guidance document, which was released  last December. Some commenters showe...