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  • Regulatory NewsRegulatory News

    Academics and Researchers Raise Concerns With FDA’s Plan for ‘Integrated Reviews’

    More than 50 academics and researchers from Harvard, Yale, Johns Hopkins and other universities around the world are calling on the US Food and Drug Administration (FDA) to not replace its original reviews of medical products with an “integrated review” because of the valuable information that would be lost. The researchers claimed that such a shift would deprive them of information and data on the clinical studies and trials submitted to FDA, information on the postmar...
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    BIO Targets Compulsory Licensing, Regulatory Reforms Across Various Countries

    Following the release of PhRMA’s Special 301 Report urging the Office of the US Trade Representative to better protect American pharma companies’ intellectual property in foreign countries, BIO has released its own report this week, with an eye toward compulsory licensing and regulatory data protection. Similar to PhRMA, BIO singles out Malaysia as a “Priority Foreign Country” following the issuance of a compulsory license in 2017 to make generic versions of Gilead’s he...
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    BIO Seeks Clarity on FDA’s Gene Therapy Draft Guidances

    Industry group BIO recently submitted comments on a series of new draft guidance documents on gene therapy released by the US Food and Drug Administration (FDA) in July. The six guidance documents focus on developing hemophilia, rare disease and retinal disorder gene therapies, and also include one on chemistry, manufacturing and control (CMC) information, one on long term follow-up observational studies collecting data on adverse events and one on the testing of retr...
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    GOP Tax Reform Bill Would Repeal Orphan Drug Research Credits

    Republicans on Thursday rolled out their new tax reform bill, which among other provisions to lower taxes for Americans and businesses, proposes to repeal a provision that might cause the biopharma industry some concern. Under the House bill’s Subtitle E, section 3401 would repeal what amounts to half of the qualified clinical research costs for designated orphan drug products. Background Under the  Orphan Drug Act  of 1983, Congress sought to incentivize the d...
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    Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports

    Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes for biologics to be documented in annual reports. The draft guidance notes that under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities or responsible personnel that have a ...
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    BIO Highlights IP Challenges Around the Globe

    As part of an effort to help the US Trade Representative understand and preserve strong intellectual property (IP) protections for US companies, the Biotechnology Innovation Organization (BIO) recently put together a report highlighting challenges worldwide and noting that IP reforms outside the US could improve conditions for exporting biotech products. "These challenges hinder or prevent innovators from securing patents (patent backlogs and restrictive patentabil...
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    BIO, PhRMA and Others Urge Further FDA Clarity on Drug Compounding

    The Biotechnology Innovation Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), Pew Charitable Trusts and other groups earlier this week sent letters to the House and Senate urging further support for FDA oversight of drug compounders and enforcement of the 2013 Drug Quality and Security Act .  "If FDA is not permitted to maintain that line between traditional compounding and outsourcing facilities, patients are put at risk, sta...
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    Industry Supports FDA Proposal to Create New Office of Patient Affairs

    Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs. The idea for the new Office of Patient Affairs (OPA), proposed in March , is part of the agency’s efforts to offer "a single, central entry point to the Agency for the patient community," as well as "triage and navigation services for inbound inquir...
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    BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products

    Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations. Background Under what’s known as the pre-request for designation (pre-RFD) program, sponsors can ask FDA how their product will be classified (drug, device, biological product or combination product), and which of the agency's three review centers will be responsible for reviewing and reg...
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    Failure to Reauthorize User Fee Programs Would Result in About 3,000 FDA Layoffs

    Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions on Tuesday that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration (FDA) would likely see more than 3,000 job cuts. Those layoffs, if Congress and President Donald Trump fail to act before 1 August or Congress’ summer recess, would significantly curtail new medical product...
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    Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance

    Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday. Background On 12 January, FDA issued a 54-page draft guidance to provide sponsors and review staff with the agency’s thinking on the problems posed by multiple endpoints in the analysis and i...
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    BIO, Pew Weigh FDA's Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics

    The Biotechnology Innovation Organization (BIO) and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration's (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics. While both organizations say the revised draft guidance is a step in the right direction, BIO says several aspects of the guidance still raise concerns. Background FDA first issued its draft guidance on mixing, diluting or repackaging biological...