• Regulatory NewsRegulatory News

    FDA Warns Three Drugmakers, Diagnostic Company

    The US Food and Drug Administration (FDA) recently warned three drugmakers for good manufacturing practice (GMP) violations and a California-based diagnostic maker for distributing reagents without submitting premarket notification or obtaining premarket approval for the tests.   Torrent Pharma   In its warning letter to Torrent Pharma, FDA cites the company for sanitary deficiencies related to its water system and for failing to thoroughly investigate failed test ...
  • Regulatory NewsRegulatory News

    EC Offers Help to Wholesalers on GDP Inspections

    To help pharmaceutical wholesalers comply with good distribution practice (GDP) inspections, the European Commission on Tuesday released a new aide memoire. The six-page document comes in the form of general questions, as well as more specific ones related to a wholesaler's quality system, verification of a medicine’s safety features, suspected falsified medicinal products and decommissioning of unique identifiers (UIs), among others. The document also offers references...
  • Regulatory NewsRegulatory News

    WHO Drafts Guideline on Data Integrity for Pharmaceuticals

    The World Health Organization (WHO) recently drafted a new guideline on data integrity that explains the important elements to ensure the reliability of data and information in the production and control of pharmaceuticals. WHO echoed similar concerns expressed by the US Food and Drug Administration (FDA) (even among some  larger biopharma companies ) in noting an uptick in recent years of the number of observations regarding the integrity of data, documentation and r...
  • Regulatory NewsRegulatory News

    Two More Deaths Linked to Intra-aortic Balloon Pumps

    The US Food and Drug Administration (FDA) said Tuesday that since notifying physicians of particular intra-aortic balloon pump (IABP) device failures last November, two more patients have died and one more serious injury has occurred. FDA in July designated Getinge’s Maquet/Datascope recall of its Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i IABPs as Class I after five patient deaths were reported since 2016. “Although the deaths cannot be definitively at...
  • ReconRecon

    Recon: CRISPR, Vertex Therapy Shows Early Benefit in First Two Patients; Donors Pledge $2.6B for Polio Eradication

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US First CRISPR treatment for blood diseases shows early benefits in two patients ( STAT ) ( Endpoints ) ( Press ) Novo Nordisk’s parent company to launch research incubator in Boston ( STAT ) ( Xconomy ) Inside Purdue Pharma’s Media Playbook: How It Planted the Opioid “Anti-Story” ( ProPublica ) Amarin releases interim EVAPORATE data — and mineral oil makes anot...
  • RoundupsRoundups

    Asia Regulatory Roundup: TGA Seeks Feedback on Requirements for Fecal Transplant Manufacturing Sites

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Seeks Feedback on Requirements for Fecal Transplant Manufacturing Sites   Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on the quality standards it plans to impose on manufacturers of fecal microbiota transplant (FMT) products. TGA wants to know how the changes will affect the sector and whether the proposed 12-month transition period is ...
  • Regulatory NewsRegulatory News

    FDA Approves Contact that Slows Nearsightedness Progression

    The US Food and Drug Administration (FDA) on Friday granted premarket approval (PMA) to CooperVision’s MiSight contact lens to slow the progression of myopia, commonly known as nearsightedness, in children ages 8-12.   This is the first FDA-approved product to “slow the progression of myopia in children, which ultimately could mean a reduced risk of developing other eye problems,” said Malvina Eydelman, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT...
  • Regulatory NewsRegulatory News

    Nonprofit Calls on FDA to Take Enforcement Action on 39 Fertility Supplements

    The Center for Science in the Public Interest (CSPI), a Washington, DC-based nonprofit, sent letters to the US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) on Monday, calling on the agencies to take enforcement action against 39 supplements purporting to aid fertility but without evidence to support their claims. CSPI said none of the manufacturers of the products could provide “scientific substantiation of their products’ claims regarding femal...
  • Regulatory NewsRegulatory News

    Should Medicines With a PASS be Excluded From Additional Monitoring? EC Says Not Yet

    The European Commission on Friday sent a report to the European Parliament and the Council on medicines that are subject to additional pharmacovigilance monitoring, including what has happened since monitoring obligations were expanded in 2010 and 2012, and what the future may hold. During the 2012 revision of the legislation, the mandatory scope of the additional monitoring list was extended to certain medicines with specific post-authorization obligations, including p...
  • ReconRecon

    Recon: Recipharm to Buy Consort Medical for £505M; FTC Approves BMS-Celgene Merger

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US BMS wins antitrust approval to buy Celgene, must divest psoriasis drug ( Reuters ) ( PMLive ) ( FTC ) Novartis sickle-cell drug gets FDA approval  ( Reuters ) ( Endpoints ) ( Fierce ) ( FDA ) ( Press ) Trump says US states will be able to buy prescription drugs abroad ( Reuters ) FDA nominee to face questions on issues from vaping to salmon ( Roll Call ) Okla...
  • Regulatory NewsRegulatory News

    EC Considers Amending Provision on Duplicate MAAs for Biologics

    Earlier this month, the European Commission’s (EC) Pharmaceutical Committee met to discuss how the use of duplicate marketing authorization applications (MAAs) — including the use of duplicate reference biologics, dubbed “autobiologicals” — can impact the availability and pricing of biological products and biosimilars. Requests for duplicate MAAs under Article 82(1) of Regulation (EC) No 726/2004 have increased steadily, and this is a trend that is likely to continue,...
  • Regulatory NewsRegulatory News

    GAO: Drugmakers Have Mixed Views on FDA, FTC REMS Actions

    A report from the Government Accountability Office (GAO) released Thursday finds that generic and branded drugmakers are split over the US Food and Drug Administration (FDA) and Federal Trade Commission’s actions to improve generic drugmakers’ access to reference drug samples when the drugs are subject to a risk evaluation and mitigation strategy (REMS).   In 2017, former FDA Commissioner Scott Gottlieb famously told drugmakers to “end the shenanigans” that inhibit g...