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    Australia Relaxes Oversight on Some Low Risk Drugs, Devices

    The Australian government has endorsed several regulatory activities aimed at reducing the Therapeutic Goods Administration’s (TGA) oversight on a range of low risk pharmaceuticals and medical devices. The changes to the therapeutic goods framework are based on more than 1,000 submissions to a March 2017 consultation. The consultation was released as part of the government’s response to TGA’s Review of Medicines and Medical Devices Regulation , identifying ways in whic...
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    PIC/S Adopts New Guidelines on Shared Facilities, Revisions to GMP Guide

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has adopted new guidelines on cross-contamination in shared facilities and implemented revisions to several of the sections in its good manufacturing practices (GMP) guide. Both the guidelines and the revisions are intended to further regulatory harmonization between PIC/S and EU recommendations. They are also both set to enter into force on 1 July 2018. The new PIC/S Aide-Memoire and PIC/S guidelines cover a ...
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    Recon: Rising Insulin Prices Spark Outrage; Six Biotechs Raise $568M in IPOs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Skyrocketing insulin prices provoke new outrage ( The Hill ) The ‘Right to Try’ Could Cost Dying Patients a Fortune ( Bloomberg ) ( Endpoints ) ( Fierce ) ( STAT ) Novo Nordisk’s ‘sema’ whips Merck’s diabetes drug rival in PhIII as it reaches for best-in-class ranking for GLP-1 group ( Endpoints ) ( Reuters ) ( PBR ) Controversial researcher’s diabe...
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    Recon: Amgen's Blincyto Gets Full EU Approval for Rare Leukemia; GSK, Gilead Headed for HIV Showdown

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  In Focus: US  Finding Cancer Patients Is the Pharma Industry’s Unlikely Challenge ( Bloomberg )  OxyContin maker Purdue Pharma cuts remaining sales force ( Reuters ) ( Bloomberg ) ( Vice )  Doudna-Charpentier team awarded U.S. patent for CRISPR-Cas9 ( Berkeley News ) ( GEN )  Anika’s combo arthritis drug Cingal flunks phase 3 test ( Fierce ) ( Endpoints ) ( BioSpa...
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    Recon: Ziopharm CAR-T Trial Put on Clinical Hold; DMD Trial Hold Lifted

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Elizabeth Holmes indicted on wire fraud charges, steps down from Theranos ( CNN ) ( Slate Magazine ) ( NYT ) ( CNBC ) ( Reuters ) ( WSJ ) ( USA Today ) PTC Therapeutics Up Most Since 2016 on Rare-Disease Drug Results ( Bloomberg ) ( Reuters ) ( Endpoints ) ( BioSpace ) Indivior shares rise after U.S. court order blocks generic rival drug ( Reuters ) ( Fierce ) Af...
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    FDA Answers Questions on Coding of IVDs

    In an effort to standardize the information gathered via in vitro diagnostic (IVD) tests, the US Food and Drug Administration issued guidance Friday providing clarifications on the distribution of codes used by manufacturers.     As adoption of electronic health record (EHR) systems continues to grow across the US, the agency argues “there has been a greater demand” for standardization of how IVDs are coded as the information from these tests “form a significant pr...
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    Australia Implements Process for Comparable Overseas Regulators

    Following a 2016 regulation aimed at improving access to medical products in Australia, the Therapeutic Goods Administration (TGA) has implemented criteria to aid pharmaceutical companies in identifying comparable overseas regulators (COR), as well as a formal process for work-sharing on drug applications using foreign reports.   The clarifications come at a time when regulators around the world are looking to harmonize regulatory requirements and reduce duplicative wo...
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    Recon: Teva Drops Chronic Cluster Headache Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Teva hit by another PhIII setback on CGRP pain drug fremanezumab, but there’s no pulling back now as rivals race ahead ( Endpoints ) ( Reuters ) ( Fierce ) ( BioSpace ) Mylan scores FDA approval of generic Suboxone for opioid addiction, but a strong launch is no sure bet ( Fierce ) ( Reuters ) ( Medscape ) ( ABC News ) ( Pharmacy Times ) $75M IPO: West Chester bio...
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    CDRH Guidance Details Labeling Considerations for Guidewires and Devices With Lubricious Coating

    In two draft guidances issued Thursday, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is providing new labeling recommendations for certain devices with guidewires or lubricious coatings. CDRH intends to ensure consistency among device sponsors when preparing premarket applications or 510(k) submissions across the different product areas with the drafted recommendations. The 12-page draft guidance on intravascular cathe...
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    Recon: Mylan Braces for FDA to Reject its Advair Copy for the Second Time

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Madrigal Pharma Is Exploring Sale After Receiving Takeover Interest ( Bloomberg ) Mylan preps for rejection of Advair copy ( BioPharma Dive ) ( Reuters ) ( Endpoints ) ViiV’s two-drug HIV regimen hits PhIII targets ( PharmaTimes ) ( Endpoints ) ( Reuters ) FDA Approves Avastin for Advanced Ovarian Cancer ( PMLiVE ) ( PBR ) Massachusetts Sues OxyContin Maker Purd...
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    FDA Classifies Brain Trauma Assays, Endoscopic Electrosurgical Clip Cutting Systems

    In final orders issued Wednesday, the US Food and Drug Administration (FDA) classified brain trauma assessment tests and endoscopic electrosurgical clip cutting systems as class II devices. Both device classifications were established via the De Novo pathway based on FDA’s review of 2016 and 2017 requests from Ovesco Endoscopy AG and Banyan Biomarkers, respectively. These in turn allow for a device sponsor of a brain trauma assay or an endoscopic electrosurgical clip cu...
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    Combination Products: FDA Proposes Alternative Mechanisms to Comply with GMP Requirements

    Manufacturers of combination products were offered a list on Tuesday of flexible mechanisms that can be used to comply with the US Food and Drug Administration’s (FDA) requirements for good manufacturing practices (GMP). The proposal satisfies a mandate from the 21 st Century Cures Act of 2016 that called on FDA to periodically issue a list identifying the types of combinations products and manufacturing processes for which “alternative or streamlined mechanisms” can...