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  • Regulatory NewsRegulatory News

    2016 CMS Data on Industry Payments to US Physicians, Hospitals: Company Breakdowns

    The US Centers for Medicare and Medicaid Services (CMS) on Friday released 2016 data on more than $8 billion in payments (which is on par with 2015 data) made by 1,481 pharmaceutical, biotech and medical device companies to more than 600,000 physicians and 1,146 hospitals. In total, CMS calculated that $2.8 billion was spent on general payments and $4.36 billion on research payments.  In its breakdown of the numbers, CMS says that more than $1 billion in 2016 was s...
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    EMA Reveals List of Eligible Industry Stakeholder Organizations

    The European Medicines Agency (EMA) on Monday disclosed a new list of eligible industry stakeholder organizations that can consult and cooperate with the agency in specific areas. The list of 17 organizations includes the trade groups European Federation of Pharmaceutical Industries and Associations (EFPIA), Medicines for Europe and the Active Pharmaceutical Ingredients Committee. EMA notes that in order to be more directly involved in EMA activities, industry st...
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    FDA and Industry: How Dangerous is the Revolving Door?

    Earlier this week, a former deputy director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) settled charges that he provided tips on drug approvals to three hedge fund managers that made tens of millions off the non-public information. The settlement raises some important questions on the so-called revolving door between industry and FDA, and what it means for patient safety. Is it OK for those in the pharmaceutical and medical device indust...
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    EU’s Pediatric Regulation: European Commission Seeks Feedback for New Report

    The European Commission (EC) on Tuesday launched a public consultation to obtain feedback for its second report on the  Pediatric Regulation,  ten years after its implementation. The comments on the consultation, which is open until 20 February 2017, will help inform the EC's report, which is expected to be published in 2017 and will assess the regulation's impact on public health and the pharmaceutical industry. Background The Pediatric Regulation, known in the EU ...
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    Former Regulatory Affairs Director Charged With Insider Trading

    The US Securities and Exchange Commission (SEC) on Thursday charged Robert Gadimian, former senior director of regulatory affairs for Puma Biotechnology, with making more than $1.1 million thanks to non-public information linked to the company’s breast cancer treatment. The SEC alleges that Gadimian pocketed the illicit profits by secretly purchasing Puma stock and short-term call options based on non-public information he learned about positive developments in two cl...
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    Prescription Drug and Biosimilar User Fees to See Major Discounts in 2017

    As an increasing number of new drug applications (NDAs) and biologic license applications (BLAs) are expected to be submitted in 2017, the US Food and Drug Administration (FDA) has lowered some of the application fees by more than $300,000. For 2017, the fee for an NDA requiring clinical data or a biosimilar application requiring clinical data will be $2,038,100, which is $336,100 less than the $2.37 million fee from 2016 . For an NDA not requiring clinical data or a ...
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    FDA Commissioner Listed in CMS Database for Receiving Payments from GSK, AstraZeneca in 2015

    In what might turn out to be an odd mistake, the current US Food and Drug Administration (FDA) Commissioner Rob Califf was included in a database of pharmaceutical company payments to physicians updated by the US Centers for Medicare & Medicaid Services (CMS) on Thursday. The database says Califf received five payments from GlaxoSmithKline for travel, lodging, food and beverages, as well as a more than $5,000 consulting fee from AstraZeneca in 2015. In 2014, when he ...
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    Biosimilar User Fees: Public Meeting Kicks Off Negotiations for BsUFA II

    The US Food and Drug Administration (FDA) began negotiations on the second biosimilar user fee program on Friday with a public meeting highlighting some of the roadblocks the agency has seen so far and what remains to be done to help make the US biosimilar market more robust. The current legislative authority for the Biosimilar User Fee Act (BsUFA) expires in September 2017, so FDA has to work with a number of stakeholders (industry, patients, academia, etc.) to devise ...
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    New Draft Guidance on Best Practices for IND Communications Between Sponsors, FDA

    Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday. The communications between FDA and industry are often opportunities to share cirtical information on clinical trials and for the agency to provide advice on trial design, dose selection...
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    PDUFA VI Reauthorization: Industry, FDA Discuss Broader Use of Real World Evidence

    Representatives from industry groups BIO and PhRMA met with officials from the US Food and Drug Administration (FDA) twice last month to discuss new plans for using real world evidence to support benefit-risk assessments for medical products, according to the meeting minutes of a subgroup of the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA). Background Congress created the Prescription Drug User Fee Act (PDUFA) in 1992 to help FDA collect fees from...
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    EMA Management Board Adopts New Framework for Industry Interactions

    The European Medicines Agency’s (EMA) Management Board has adopted a framework that seeks to streamline and structure industry-agency communications, as well as to increase transparency around those discussions. The framework , first announced in early October, comes as the agency has grown in size and scope to the point where its approach to managing interactions with industry have become fragmented. The interactions will cover areas of common interest for the agency a...
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    Industry Conflicts With FDA: The Options

    Pharmaceutical companies concerned by US Food and Drug Administration (FDA) actions or decisions have a number of informal and formal ways to get in touch with and file appeals with the agency, two FDA officials told attendees at RAPS’ Regulatory Convergence last month. The conversation on disputes came as FDA in September further clarified and updated its guidance on how it resolves complicated medical and scientific disagreements between industry and FDA. Informal D...