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    FDA to Congress: Pediatric Information Lacking in 36% of Relevant Orphan Drug Labels

    In a report to Congress, the US Food and Drug Administration said that there is a public health need for additional pediatric information in labeling for over one-third of approved orphan indications that are relevant in the pediatric population. FDA research, conducted as part of the FDA Reauthorization Act of 2017  (FDARA), found that of all drugs that were approved for an orphan indication between 1 April 1999 and 31 August 2018, a total of 548 orphan indications we...
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    Michigan Senator Raises Concerns With FDA Over High Numbers of Drug Shortages

    As drug shortages continue to increase in the US, Sen. Gary Peters (D-MI) on Wednesday sent a letter to Acting US Food and Drug Administration (FDA) Commissioner Ned Sharpless seeking more information on what FDA will do. Peters, ranking member of the Committee on Homeland Security and Governmental Affairs, called FDA’s current efforts to combat shortages “not sufficient, given the current state of rising drug shortages in our nation.” He also wrote that he’s “increasin...
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    Senate Coalesces Around Series of Drug Pricing Bills With Little Impact on Pharma Companies

    The Senate Judiciary Committee on Thursday advanced four bills to the Senate floor, three of which were bipartisan, and all meant to lower the prices of prescription drugs. The four bills are part of a coordinated push in the Senate and include a larger bill that advanced Wednesday out of the Senate health committee and is expected to be taken up on the Senate floor before the end of July, and another bill that Sen. Chuck Grassley (R-IA) said he was likely to advance ...
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    MHRA Consults on Analytical Quality by Design Principles

    The UK’s Medicines and Health care products Regulatory Agency (MHRA) on Tuesday opened a three-month public consultation on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeial standards.   “Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management,” MHRA writes.   Th...
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    OPQ Reports on State of Drug Quality in FY2018

    In a report released Monday, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) provides a look at the pharmaceutical quality landscape for drugs and biologics intended for the US market.   The report itself breaks down different metrics related to product quality and manufacturer compliance with current good manufacturing practice (cGMP) to paint a picture of the overall pharmaceutical quality landscape.   While FDA reports an overa...
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    Experts Tell Device Companies Not to Fret Over QMS Transition

    Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...
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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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    Patient Groups, Industry Seek Changes to Rare Disease Drug Guidance

    Patient groups, drugmakers and other organizations are calling for changes to the US Food and Drug Administration’s (FDA) recently revised draft guidance on developing drugs to treat rare diseases.   The 24-page draft guidance was revised last February after first being published in 2015. The revision included updates to the agency’s approach to natural history studies, a discussion of issues for evaluating biomarkers for consideration as surrogate endpoints and a ne...
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    Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars

    The European Medicines Agency (EMA) and European Directorate for the Quality of Medicines and Healthcare (EDQM) on Thursday released a report detailing findings from EMA’s drug sampling and testing program over the last 20 years.   EMA says it plans to extend the program to include biosimilars and that it will expand the generic sampling and testing program first launched in 2011 to include products authorized via the mutual recognition and decentralized procedures. ...
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    ICH Advances Revised Guideline on Elemental Impurities

    The internationally harmonized guideline for a risk-based approach on assessing and controlling elemental impurities in drug products entered the final implementation phase. ICH Q3D(R1) Guideline for Elemental Impurities, developed via the International Council for Harmonisation (ICH), reached the fourth out of five steps in ICH’s process of regulatory harmonization last week, moving toward implementation of the revised guideline. The guideline was first recommended for...
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    FDA Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on the nonclinical studies drugmakers should conduct when developing products to treat severely debilitating or life-threatening hematologic disorders (SDLTHDs).   FDA classifies SDLTHDs as hematologic conditions that cause shorter life expectancy or greatly diminished quality of life even with available treatments.   FDA notes that the guidance does not apply to hematologic cancers and covers...
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    FDA to Survey Healthcare Professionals on Prescription Drug Marketing

    The US Food and Drug Administration (FDA) on Friday announced it will go ahead with a survey of healthcare professionals (HCPs) on how they are impacted by prescription drug promotion aimed at a professional audience.   The announcement comes after the agency consulted on its plans for  the survey in March 2018 and follows two earlier surveys that looked at HCPs’ attitudes toward direct-to-consumer (DTC) advertising. The survey will also include questions about HCPs’...