• Regulatory NewsRegulatory News

    FDA, with academic and community partners, launches first pediatric ECG warehouse

    Pediatric electrocardiogram (ECG) data being collected by the US Food and Drug Administration are now available in a first-of-kind data warehouse.   The warehouse, a mirror of a similar data warehouse for adult ECG data, collects and makes available a rich store of information “to enhance cardiac safety review for therapeutic product development for children,” according to a new FDA Spotlight article announcing the launch of the warehouse.   One prong of the wo...
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    CDRH official offers advice for smoother Q-submission meetings

    A policy analyst with the US Food and Drug Administration (FDA) walked through mechanisms the medical device industry can use to request pre-submission meetings, as well as best practices for ensuring smooth reviews.   Susannah Gilbert, Q-submission program lead with the division of regulatory programs at FDA’s Center for Devices and Radiological Health (CDRH), gave the updates at a 21 July webinar sponsored by the FDA’s Small Business Regulatory Education for Industry...
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    Citizen Petitions Delaying Approvals: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance discussing some of the considerations that the agency will take into account when determining whether citizen petitions and petitions for a stay of agency action are submitted with the primary purpose of delaying the approval of a pending generic drug, biosimilar or 505(b)(2) application. The final guidance comes as FDA in February explained its concerns to Congress that such petitions are often...
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    Drugmaker Petitions FDA to Revoke Sublocade Orphan Designation

    A citizen petition filed last week by law firm Goodwin Procter on behalf of Pennsylvania-based drugmaker Braeburn calls on the US Food and Drug Administration (FDA) to revoke the orphan designation granted to Indivior’s opioid use disorder treatment Sublocade (buprenorphine extended-release injection).   “Sublocade is not now, nor was it ever a bona fide orphan drug, particularly since more than two million Americans currently are afflicted by opioid addiction,” the pe...
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    Trump’s 2020 Budget Seeks FDA Tweaks to Increase Generic Competition

    With Democrats controlling the House, the specifics of President Donald Trump’s Fiscal 2020 budget, released on Monday, may not matter much, but it does feature new attempts to alter US Food and Drug Administration (FDA) processes in order to increase generic drug competition. Similarly to last year’s budget , the 2020 budget looks to save more than $1 billion in Medicare and Medicaid funds by stopping some generic drug applicants, who file first and win tentative appr...
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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 Raises Concerns With 505(q) Petitions

    In a report to Congress, the US Food and Drug Administration (FDA) took issue with a certain statute that requires FDA to prioritize petitions seeking to delay product approvals above other safety petitions that raise public health concerns. “FDA continues to be concerned that section 505(q) does not discourage the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues,” the agency sa...
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    FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices

    The US Food and Drug Administration (FDA) issued final guidance Thursday on the coordinated development of antimicrobial drugs and susceptibility assays, with additional clarifications. The finalization follows concerns raised by AdvaMed and BIO with the 2016 draft guidance’s lack of language to address the issue of antimicrobial susceptibility breakpoints among drug and medical device sponsors. The issue relates to leveraging the use of ka breakpoint as a vehicle for a...
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    FTC Backs FDA Draft Guidance to Stem the Tide of Abusive Citizen Petitions

    The Federal Trade Commission (FTC) has offered its support for revised US Food and Drug Administration (FDA) draft guidance that will use additional criteria to determine if a citizen petition was submitted to delay the approval of a competing drug. The revised draft offers new considerations for FDA when reviewing citizen petitions, including if a petition was submitted near the expiration of known patent or exclusivity, if a petition was the same or substantially simi...
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    FDA Denies Novo Nordisk Petition on Liraglutide Generics

    The US Food and Drug Administration (FDA) on Friday denied Novo Nordisk’s citizen petition that aimed to block generic versions of its blockbuster insulin Victoza (liraglutide) and two other products containing liraglutide. Novo argued that the Type 2 diabetes drugs containing liraglutide are large and complex molecules and that a manufacturing process that differs from its own might have unintended consequences. The company also argued that FDA has not issued guidan...
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    FDA Denies 3rd Allergan Citizen Petition to Block Restasis Generics

    The US Food and Drug Administration (FDA) on Wednesday denied Allergan's third citizen petition attempting to block the agency from approving generic versions of the company's blockbuster Restasis (cyclosporine ophthalmic emulsion). "This is Allergan's third petition concerning the methods an ANDA [abbreviated new drug application] applicant might use to demonstrate that a proposed generic drug is bioequivalent to Restasis. As in its previous petitions and commen...
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    Updated: The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US

    Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years. In September, FDA granted tentative approval for Sanofi’s Admelog (insulin lispro injection), a rapid-acting human insulin analog. On 11 December, Admelog received full approval from FDA. In the EU, howe...