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    Antimicrobial Resistance: FDA Discusses Reimbursement Reforms

    Reimbursement reforms for antimicrobial treatments could include “a mix of milestone payments and subscription fees for developers of FDA-approved products with high economic and clinical value, targeted at multi-drug resistant organisms and linked to proven clinical outcomes,” US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said in a speech at Pew Charitable Trusts on Friday.   He also offered the idea of using a “subscription-based model” that could...
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    Updated: FDA, Health Canada and EMA Spot Second Impurity in Valsartan

    Following the identification of an impurity known as N‑nitrosodimethylamine (NDMA) in the blood pressure - lowering medicine valsartan, FDA, EMA and Health Canada announced Thursday that a second impurity, called N-nitrosodiethylamine (NDEA), has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals in China. FDA also said Thursday that its latest testing of products shows an additional unexpected impurity in three lots of  Torrent Pharmaceuticals’ rec...
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    FDA Looks to Build Diagnostics Framework Centered on Accuracy, Reliability and Safety

    As Congress crafts new legislation on diagnostics to update a system first built in 1976, the US Food and Drug Administration (FDA) has offered feedback that will help to shape a modern framework whereby diagnostics can be relied on as accurate and safe, FDA Commissioner Scott Gottlieb said in a speech Thursday to the Friends of Cancer Research’s 7th Annual Blueprint for Breakthrough Forum. Gottlieb noted that FDA envisions a world in which, “eventually, fewer than 10 p...
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    BIO, Allergan and Roche Call for FDA Flexibility With Patient Experience Data

    Industry group BIO and biopharma companies Allergan and Roche are calling for the US Food and Drug Administration (FDA) to be flexible in its approach for using patient experience data (PED) and in allowing the use of such data in labeling. BIO said that it “strongly believes” that in order for a broad adoption of PED, any upcoming guidance documents on patient-focused drug development “should emphasize the FDA’s willingness to exercise regulatory flexibility and accept...
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    ANDA Technical Specifications: FDA Guidance

    The US Food and Drug Administration on Wednesday offered new recommendations on how certain comparative clinical endpoint bioequivalence study data and skin adhesion and irritation/sensitization study data for abbreviated new drug applications (ANDAs) should be submitted using FDA-supported data standards located in the  FDA Data Standards Catalog .   The guidance is intended to complement interactions between applicants and FDA review divisions, though it is not inten...
  • Chinese API Manufacturer Refuses EU Officials’ Inspection

    China-based active pharmaceutical ingredient (API) and intermediate manufacturer Jiangsu Yew Pharmaceutical Co. has refused an inspection by Hungarian officials and has been found to not comply with Good Manufacturing Practice requirements, according to a European database of pharmaceutical inspections updated Wednesday. The refusal of the inspection on 20 June means the company, which manufactures intermediates for the active substance temozolomide, will not win approv...
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    Chinese, Canadian Drugmakers Receive FDA Warning Letters

    The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent to China-based Longood Medicine (Beijing) Co., Ltd. and Quebec-based Lernapharm Inc. For Lernapharm, which manufactures safety lancets, FDA raised a number of questions about the firm’s sterility for products labeled sterile. FDA found the firm reprocessed multiple batches of certain drug products purporting to be sterile, but which “did not meet process parameters or quality attri...
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    FDA Looks to Make FOIA Process Easier

    The US Food and Drug Administration (FDA) on Wednesday proposed a new rulemaking that would ease the process by which the public can use the Freedom of Information Act (FOIA) to request certain non-public information. In addition to easing the process by which materials can be requested, the proposed rule will require FDA to establish procedures for identifying records of general interest or use to the public that are appropriate for public disclosure, and for posting s...
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    OIG to FDA: Better Integrate Cybersecurity Into Device Review Process

    The Department of Health and Human Services’ Office of the Inspector General (OIG) is calling on the US Food and Drug Administration (FDA) to further integrate cybersecurity into its review processes for medical devices. The recommendation comes as OIG notes that currently, FDA’s “Refuse-To-Accept” checklists, which the agency uses to screen submissions for completeness, do not include checks for cybersecurity information. In addition, FDA’s “Smart” template, which is u...
  • FDA Releases Handful of Recent Form 483s

    The US Food and Drug Administration (FDA) on Monday released five Form 483s sent to manufacturers in India, Japan and the US either because they had been frequently requested or because FDA wanted to proactively post the reports. Cook Pharmica Bloomington, Indiana-based Cook Pharmica received this Form 483 on 1 May, following a seven-day inspection in late April. The redacted Form 483 includes five observations, including one for “an unacceptably high number of mol...
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    Post-approval Changes to Drug Substances: FDA Drafts Guidance

    Drugmakers looking to make a change to the drug substance manufacturing process during an application’s post-approval period should consult the US Food and Drug Administration’s (FDA) new draft guidance released Monday. The 38-page draft, completed as part of a commitment to the reauthorization of the Generic Drug User Fee Amendments (GDUFA II), provides recommendations to holders of approved new drug applications, abbreviated new drug applications, new animal drug appl...
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    Senate to Vote This Week on Opioid Bill With FDA Provisions

    The Senate will vote later this week on a sweeping, bipartisan opioid bill that will seek to slow the opioid epidemic that killed more than 70,000 in 2017. Among the more than 70 proposals included in the bill are several related to the US Food and Drug Administration (FDA), the National Institutes of Health and other Department of Health and Human Services agencies. “The House has already passed its version of the act, and there is a bipartisan urgency to work wit...