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    FDA clarifies reporting post-approval changes for disposable manufacturing materials

    The US Food and Drug Administration (FDA) on Friday issued a question-and-answer guidance  to provide clarity to manufacturers on reporting post-approval changes to disposable manufacturing material.   The guidance covers changes made to new drug applications (NDAs), biologics license applications (BLAs) or abbreviated new drug applications (ANDAs) and applies to all manufacturing establishments, including those that perform functions under contract.   During the...
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    FDA blasts US API firm for lax response to mold contamination, data integrity failings

    A US manufacturer of active pharmaceutical ingredients (API) was lambasted in a recent warning letter by the US Food and Drug Administration (FDA) for multiple good manufacturing practice (GMP) violations, one of which was a failure to adequately respond to mold contamination.   The firm also failed to maintain control over its computer systems to prevent unauthorized access to electronic data.   The warning letter was issued on 18 July to St. Louis-based manufactu...
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    Recon: Senate Democrats agree on $430 billion reconciliation bill with drug pricing measures; Cassava faces criminal probe over falsified data for Alzheimer's drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Democrats Manchin, Schumer agree on $430 billion tax, drugs, energy bill ( Reuters ) ( Endpoints ) ( Inside Health Policy ) ( Politico ) Two sides of 'historic' drug pricing bill: Pharma industry blasts 'mistake' while advocates plan for 'first ever' gains ( Endpoints ) Merck CEO concerned about proposed drug pricing bill hurting innovation ( Reuters ) GSK’s B...
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    EMA to address nitrosamine impurities in upcoming revision of active substances guidance

    The European Medicines Agency (EMA) will be updating its guideline on active substances to incorporate strategies for controlling and preventing nitrosamines in drug products and active pharmaceutical ingredients (APIs), the agency announced in a new concept paper .   The revised guideline is meant to address risk factors for formation of nitrosamines in medicinal products and strategies for preventing their formation and presence.   EMA and other regulators have ...
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    Neonatal drug development addressed in FDA final guidance

    The US Food and Drug Administration (FDA) issued final guidance this week to assist sponsors in developing clinical pharmacology studies for neonatal populations. The guidance is meant to address gaps in neonatal labeling and encourage the development of therapies that are “unique to neonates.”   The guidance is tailored to sponsors developing these studies for investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications ...
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    FDA announces plans to revamp national drug code

    The US Food and Drug Administration (FDA) on Monday proposed an update to the National Drug Code (NDC), replacing the existing 10-digit format with a 12-digit format in anticipation of a looming exhaustion of these codes within the next ten to 15 years.   The rule would retain the three-segment code consisting of the labeler code, the product code and the packaging code. The NDC is used to register and track pharmaceutical products through the supply chain.   Under...
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    Recon: Biogen nabs priority review for ALS therapy, despite phase 3 miss; Pfizer, BioNTech file US suit against CureVac

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Ever the optimist, Biogen secures FDA priority review for ALS drug that flunked phase 3 ( Fierce ) ( Reuters ) ( Endpoints ) ( STAT ) Novartis generics arm files for MS biosimilar, challenging Biogen; Pluristem shortens name ( Endpoints ) Incurable Cancer Patients to See Eased Path to Clinical Trials ( Bloomberg ) Out-of-pocket cap will increase the net price ...
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    Recon: Biden admin embarks on effort to develop next-gen COVID-19 vaccines; EU approves Bavarian Nordic’s Monkeypox vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House to launch effort to develop next generation of Covid vaccines ( STAT ) ( Barrons ) FDA puts the microscope on 2 more cancer approvals without voluntary withdrawals ( Fierce ) Biden administration weighs declaring monkeypox a health emergency ( Washington Post ) ( Reuters ) Monkeypox ‘Can Be Contained” in US, White House Doctor Says ( Bloomberg ) S...
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    FDA describes plans to expand remote regulatory assessments

    The US Food and Drug Administration (FDA) released draft guidance on Friday that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as it eases out of pandemic response mode. The guidance covers triggers for when FDA will request or require remote assessments and how these audits will be coordinated with onsite inspections.   These tools are not intended to replace onsite inspections but inste...
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    FDA warning letter tells Spanish API firm to up its validation game

    A Spanish producer of active pharmaceutical ingredients (API) was chastised by the US Food and Drug Administration (FDA) in a June 30 warning letter for its spotty approach to validation and ensuring that manufacturing processes remain in a state of control and can consistently produce a quality product.   The letter to Bioiberica SAU in Barcelona, Spain, which makes heparin-based products, in addition to APIs, follows an inspection between 31 January and 4 February ...
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    Dose banding: FDA aims to reduce drug waste in new labeling guidance

    The US Food and Drug Administration (FDA) has released draft guidance to assist sponsors with incorporating dose banding information in drug labeling for ready-to-use containers in new drug applications (NDAs), biologics license applications (BLA) or supplements to those applications.   Dose banding refers to dosing a drug product based on weight or body surface area (BSA), and labeling can include a range of different strengths.   This approach reduces “signific...
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    Recon: CDC clears fourth COVID-19 vaccine; Merck’s Keytruda hit with setback after failed head and neck cancer trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A fourth Covid vaccine is cleared for use in the United States. ( NYT ) ( STAT ) ( Reuters ) ACIP Nod For Novavax’s COVID Vaccine Comes With Criticism On Lack Of Expiration Date Packaging ( The Pink Sheet ) FDA carryover funds to pay staff to last until November, Burr says ( Politico ) FDA slaps ImprimisRx with a warning letter over sponsored articles in medic...