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  • Regulatory NewsRegulatory News

    FDA warns California-based CDMO, Mexican drugmaker

    The US Food and Drug Administration (FDA) earlier this month warned two companies, contract development and manufacturing organization (CDMO) Stason Pharmaceuticals and Mexican drugmaker Signa SA de CV.   Stason Pharmaceuticals, Inc.   In its warning letter to Irvine, CA-based CDMO Stason Pharmaceuticals, FDA cites the company for product testing and data integrity issues uncovered during a three-week inspection last October.   According to FDA, the company w...
  • Regulatory NewsRegulatory News

    FDA exempts additional Class II devices from 510(k) requirements

    The US Food and Drug Administration (FDA) on Tuesday finalized an order to exempt five types of Class II medical devices from 510(k) requirements, which the agency says will decrease regulatory burdens on industry for makers of those devices.   Under the 21 st Century Cures Act , FDA was instructed to publish lists of Class I and Class II devices it would exempt from 510(k) requirements at least once every five years. In 2017, FDA exempted more than 70 Class I device...
  • ReconRecon

    Recon: US pays $1.95B for Pfizer, BioNTech COVID-19 vaccine; Biogen lifts forecast on Tecfidera sales

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer Gets $1.95 Billion to Produce Coronavirus Vaccine by Year’s End ( NYTimes ) ( Press ) Exclusive: Novavax executives could get big payday even if vaccine fails ( Reuters ) Among biotech venture capital firms, Flagship Pioneering got the best single-fund returns ( STAT ) White House considers drug pricing executive order, prompting GOP pushback ( The Hill...
  • Regulatory NewsRegulatory News

    Drugmakers to Congress: Trust an FDA-approved COVID-19 vaccine

    The public should have confidence in any COVID-19 vaccine approved by the US Food and Drug Administration (FDA), according to the testimony presented by five top pharmaceutical executives at a hearing of the House Energy & Commerce Subcommittee on Oversight and Investigations on 21 July.   The executives – representing AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer – also stressed that the agency does not appear to be lowering its standards to rush a vacci...
  • ReconRecon

    Recon: Drugmakers boost lobbying amid pandemic rush; Biogen to study Spinraza in patients treated with Zolgensma

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pharma Firms Boost Lobbying in Race for Virus Treatment, Vaccine ( Bloomberg ) ( STAT ) US Accuses Two Hackers of Stealing Secrets From US Firms for China ( WSJ ) White House to resurrect rebate rule ( Politico ) Biogen to study Spinraza in combination with $2 million Novartis drug ( Reuters ) ( Press ) Gilead lines up a $1.55B biotech buyout deal as CEO Dan ...
  • Regulatory NewsRegulatory News

    FDA issues enforcement policy for coronavirus transport media

    The US Food and Drug Administration (FDA) on Monday issued an immediately effective guidance to boost the availability of transport media intended to be used to transport clinical specimens for SARS-CoV-2 assays during the coronavirus disease (COVID-19) pandemic.   The guidance applies to transport media for both molecular and antigen diagnostic tests and covers Class I transport media devices falling under seven different product codes: JSG, JSM, JSL, JSN, LIO, JTW ...
  • Regulatory NewsRegulatory News

    New EMA pharmaceutical water quality guideline takes effect February 2021

    The European Medicines Agency (EMA) on Monday issued a new guideline on the quality of water for pharmaceutical use that will replace its nearly two-decades-old guidance and position statement on water quality when it takes effect in February 2021.   The adoption of the guideline follows a public consultation that kicked off in November 2018, with EMA making mostly minor changes to the guideline aside from revisions to the table listing minimum acceptable quality o...
  • ReconRecon

    Recon: Oxford, CanSino coronavirus vaccines trigger immune response; GSK buys 10% stake in CureVac

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House seeks to block funds for coronavirus testing and tracing in relief bill ( CNBC ) Mistrust of a Coronavirus Vaccine Could Imperil Widespread Immunity ( NYTimes ) Inside Johnson & Johnson’s nonstop hunt for a coronavirus vaccine ( NYTimes ) More than 100,000 have signed up for coronavirus vaccine testing ( The Hill ) Gene Therapy Shows Promise For H...
  • Regulatory NewsRegulatory News

    Updates on MDR implementation, transparency; MDCG posts CEAR template

    The European Commission over the past week provided several updates on the implementation of the Medical Device Regulation (MDR) and released a fact sheet explaining the information that will be available to the public about devices under the regulation.   The Commission’s Medical Devices Coordination Group (MDCG) also released a template for clinical evaluation assessment reports (CEAR) for notified bodies to document their assessments of clinical evidence for medic...
  • ReconRecon

    Recon: EU in talks to secure COVID-19 vaccines; NICE backs Astellas’ Xospata

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Three more biotechs tumble onto Wall Street today, raising $475M as the IPO party rocks on ( Endpoints ) CDC to recommend against retesting coronavirus patients before they end isolation ( Politico ) The Latest: 3M files lawsuits for price gouging of N95 masks ( AP ) Corbus Pharma is nearing the readout of a pivotal drug study. Here’s what you need to know ( S...
  • Regulatory NewsRegulatory News

    House committee advances bills aimed at orphan exclusivity, generic labeling and continuous manufacturing

    The House Energy and Commerce Committee on Wednesday advanced 17 health-related bills for consideration by the House, several of which have implications for the US Food and Drug Administration’s (FDA) oversight of orphan drugs, imported medical devices and labeling.   (RELATED: House committee discusses bipartisan bills on orphan exclusivity, generic drug labels and more , Regulatory Focus 29 January 2020).   “These bills will expand coverage and access to car...
  • ReconRecon

    Recon: J&J to begin coronavirus vaccine clinical trials; Novartis says it will offer ‘no profit’ generics for COVID-19 to 79 countries

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Johnson & Johnson Readies to Start Covid-19 Vaccine Studies ( WSJ ) J&J earnings drop 35% as pandemic delays elective procedures ( Financial Times ) Chief Vaccine Scientist Will Not Be Forced to Disclose Pharmaceutical Stocks ( NYTimes ) Abbott Laboratories Gets Boost From US Covid-19 Testing ( WSJ ) Congress Set to Tackle Vaccine Funding in Next Round of Cor...