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  • Regulatory NewsRegulatory News

    EMA Updates Q&A on Article 31 Referrals

    The European Medicines Agency (EMA) on Tuesday issued a new version of its questions and answers (Q&A) guide on Article 31 non-pharmacovigilance referrals. Background In the EU, an Article 31 referral is a procedure in which member states or the European Commission may request that EMA conduct a scientific review of a medicine for quality, safety or efficacy reasons. Unlike Article 20 referrals, Article 31 referrals may apply to any medicine or class of medicine autho...
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    House Committee Raises 'Grave Concerns' Over Patient Impact of NIH Closure of Drug Production Unit

    The House Energy and Commerce Committee is asking the National Institutes of Health (NIH) for more information on how the temporary closure of its drug manufacturing facility has impacted patients in NIH clinical trials. Background The US Food and Drug Administration (FDA) earlier this summer uncovered a series of deficiencies at NIH's Pharmaceutical Development Section (PDS), which acts as a specialty compounding pharmacy managing investigational drugs for clinical tri...
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    NIH Plots out Path Forward After Disastrous FDA Inspection

    • 22 June 2015
    The National Institutes of Health (NIH) says it is working quickly to figure out how to correct major deficiencies uncovered by the US Food and Drug Administration (FDA) last month at one of its drug compounding facilities. Background On 4 June 2015, NIH issued a statement saying it had "suspended operations" at its Pharmaceutical Development Section (PDS) following an inspection by FDA that found "a series of deficiencies." PDS is NIH's pharmaceutical development arm,...
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    FDA Guidance Explains How Medical Device Companies Can Rely on Foreign Clinical Data

    New draft guidance issued by the US Food and Drug Administration (FDA) seeks to make it easier for medical device companies to rely on data obtained from clinical studies outside the US, provided those studies are conducted to appropriate federal standards. Background The draft guidance document, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States , is closely related to a rule proposed by FDA in February 2013. That rule, Hum...
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    How can FDA be Improved? Patient Groups Offer Ideas

    More than a dozen patient groups and trade associations are offering their advice to the US Food and Drug Administration (FDA) on ways the agency can improve its regulatory and administrative processes to take into account the views and expertise of patients and their advocates. Background Since 2012, FDA has launched several initiatives meant to better take into account the views of patients. Some, like its patient-focused drug development initiative , have involv...
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    FDA Seeks Patient Insight Into Autism, Depression and 14 Other Conditions

    The US Food and Drug Administration (FDA) has announced a second batch of meetings intended to facilitate the development of drugs for neglected conditions by taking into account the perspective of the patients suffering from the conditions. Background In recent years, some patient groups—and in particular groups representing patients suffering from serious diseases with few or no suitable treatments—have begun to express their concerns that FDA is too stringent when it...
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    Australia’s TGA Clarifies Drug Approval Process in New Document

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) this week issued a new question and answer (Q&A) guidance  concerning the registration process for new prescription drugs, as well as how to make changes to an already registered product that involves clinical, nonclin...
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    FDA Unveils Policies Meant to Boost Safety, Efficacy of Medical Products for Women, Minorities

    The US Food and Drug Administration (FDA) has released new recommendations on the inclusion of women and other minorities in clinical trials, citing the need to better represent populations which have historically not been adequately included in clinical research. Background When the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in 2012, among its many provisions was Section 907. The section required FDA to publish a report "addre...
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    FDA Flexes New Inspection Authority, Banning Company After it Refuses to be Inspected

    The US Food and Drug Administration (FDA) has placed a Chinese pharmaceutical manufacturer on an import alert, banning the company's products from entering the country after it allegedly refused to allow access to FDA investigators. The company, Beijing Shunxin Meihua Bio-technical Co., was placed on import alert by FDA on 22 July 2014. FDA's import alerts—one for refusing inspection , and the other for failing to operate according to good manufacturing practi...
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    FDA Planning Five Guidance Documents to Help Children With Rare Diseases

    • 10 July 2014
    The US Food and Drug Administration (FDA) has released a new report indicating four core ways it plans to accelerate the development of treatments for pediatric rare diseases (PRD). The report, Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases , was required under Section 510 of the Food and Drug Administration Safety and Innovation Act ( FDASIA ) and based off a...
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    FDA to Provide Guidance on Use of Economic Information, Responses to Unsolicited Requests

    US regulators are planning to release several additional guidance documents by the end of the year relating to scientific exchanges of information and other promotional-like activities, including a long-awaited guidance document on the use of healthcare economic information. Background The US Food and Drug Administration (FDA) recently released two draft guidance documents intended to clarify how it treats scientific and medical literature. The first of those guida...
  • Regulatory NewsRegulatory News

    As FDA Takes Notice of Patients, Groups Trying to Influence Regulatory Policy do as Well

    An advocacy group focused on accelerating the discovery and approval of new therapies—and in particular therapies for under-served and rare diseases—has launched a new effort aimed at helping to bring patient perspectives into the regulatory process. Background In recent years, regulators and regulatory-minded groups alike have pressed to increase the involvement of patients in the regulatory process. The thinking is that patients are the best stakeholders to ask a...