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  • Regulatory NewsRegulatory News

    Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

    More than a dozen drugmakers have offered comments on the US Food and Drug Administration’s (FDA) draft guidance on postapproval changes for drug substances, with some offering changes and others calling for the document to better reflect guidance from the International Council for Harmonisation (ICH). The draft guidance covers facility, scale and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, ra...
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    Continuous Manufacturing: Pfizer, Vertex, AstraZeneca and Others Weigh FDA Plans

    The US Food and Drug Administration (FDA) has been encouraging the adoption of continuous manufacturing techniques for years, and several companies recently offered the agency some suggestions to refine its work around the developing technology. Background In contrast to batch manufacturing - where bulk materials are processed through multiple steps and subsequent batches must wait until the current batch is finished – continuous manufacturing allows companies to m...
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    Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance

    Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday. Background On 12 January, FDA issued a 54-page draft guidance to provide sponsors and review staff with the agency’s thinking on the problems posed by multiple endpoints in the analysis and i...
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    Asia Regulatory Roundup: CFDA Offers Guidance on Device Quality Control (10 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guidance on Quality Control of Medical Devices China Food and Drug Administration (CFDA) has posted guidance on quality control and finished product release for medical devices. The document details the procurement control procedures, finished product inspection rules and other processes CFDA wants companies to establish to ensure medical devices meet manda...
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    Illumina, Genentech and BIO Weigh in on FDA Draft Guidance on Companion Diagnostics

    The six public comments on the US Food and Drug Administration’s (FDA) draft guidance on companion diagnostics were mostly positive, with Genentech calling the draft “crucial for the advancement of personalized medicine,” while Illumina said it was “worth the wait,” though all commenters expressed interest in more clarity from FDA. Background The long-awaited draft guidance, released in July , was in the works for more than a decade and is meant to be a practical guid...
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    European Regulatory Roundup: AstraZeneca Pulls Cancer Drug After Disagreement With EMA (29 September 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. ‘Differences of Opinion’ with EMA Prompt AstraZeneca to Pull Cancer Drug Filing AstraZeneca has withdrawn its EMA marketing authorization application for cediranib in a subset of ovarian cancer patients. The company took the action after running into “differences of opinion” with EMA about the side effects of the drug and the way the study was run, The Telegraph repor...
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    Industry Weighs in on FDA Draft Guidance on Infectious Disease NGS-Based Diagnostics

    Diagnostic companies Illumina, Roche, AstraZeneca and others are offering a peek inside how they view next-generation sequencing (NGS) diagnostic devices, with the release of 20 comments on recent US Food and Drug Administration (FDA) draft guidance. "Next generation sequencing has the capability to replace previous methods with a single approach to accomplish what might have required several different tests in the past," FDA explains. "In contrast to human sequencing di...
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    PDUFA Reauthorization: AstraZeneca Offers Detailed Recommendations

    Although the performance and procedural goals for the sixth iteration of the Prescription Drug User Fee Act (PDUFA ) were laid out last month, pharmaceutical companies, including AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the program from fiscal years 2018 through 2022. Background On 15 July, the US Food and Drug Administration (FDA) released for comment a 46-page document outlining how the agency will use t...
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    Drug Companies Reveal Shortcomings in FDA Draft Guidance on Generic Topical Patches

    Mylan, Perrigo, AstraZeneca and Apotex are seeking more clarity and raising questions with the shortcomings of US Food and Drug Administration (FDA) draft guidance aiming to improve the way adhesion data is used for abbreviated new drug application (ANDA) submissions of transdermal delivery systems and topical patches. The draft guidance, released in May , describes the recommended approach for an adhesion clinical study design and, once finalized, the guidance will sup...
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    TransCelerate Progress on Trial Efficiencies Unimpeded by Pharma Regulators

    The joint efforts of 18 biopharmaceutical companies, under the umbrella of TransCelerate BioPharma, are continuing to advance their efforts in sharing data, making clinical trials more efficient and working with drug regulators around the world to ensure that progress enables change that can help patients. The group is working to leverage the data and best practices of its members, such as Pfizer, Amgen, AstraZeneca, Merck and Roche, across a wide swath of trial-relate...
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    FDA Offers New Draft Guidance on Bioequivalence Studies for 19 Generics, 19 Revisions

    The US Food and Drug Administration (FDA) on Thursday released 38 new and revised draft guidance documents for drugmakers looking to begin research and development for new generics, including for some blockbuster drugs that have not yet lost patent protection. The new draft documents focus on what types of bioequivalence (BE) studies may need to be conducted to obtain abbreviated new drug application (ANDA) approval. Each document also contains information on what analyt...
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    Updated: Governor Takes Issue With Super Bowl Drug Ad as New House Bill Looks to Restrict DTC Pharma Advertising

    [Editor's note: This story was updated with new details on the text of the DeLauro bill to restrict DTC pharma advertising and new details on a letter from AstraZeneca to Gov. Shumlin]. Vermont Gov. Peter Shumlin (D) has sent a letter to pharmaceutical companies AstraZeneca and Daiichi Sankyo calling on them to pull their advertisement that aired during the Super Bowl. The ad promoted a drug to treat opioid-induced constipation. “Like many Americans, I was baffled by th...