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    OPDP Letters: FDA Closes Out 2017 With Record Low

    In the last days of 2017, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to over-the-counter (OTC) drugmaker Avanthi, Inc. for omitting risk information in a panel for the weight loss drug Lomaira (phentermine hydrochloride USP). The warning letter brings the total number of enforcement letters issued by OPDP in 2017 to four (three warning letters and one untitled letter), a record low for the agency. Whi...
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    FDA Targets Multiple Review Cycles With New Draft Guidance, MAPP

    Fresh out of a record year for generic drug approvals, the US Food and Drug Administration (FDA) on Wednesday kicked off the new year by releasing new draft guidance and a new manual of policies and procedures (MAPP) with an eye toward decreasing the number of review cycles abbreviated new drug applications (ANDAs) undergo before approval. Multiple review cycles has been an outstanding challenge for the agency in years past, with less than 10% of ANDAs winning ap...
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    Ruling Against Novartis Could Have Wider Implications for Generic Drug Labels

    California's Supreme Court on Thursday ruled against Novartis in a decision that could have wider implications for whether brand-name or generic drugmakers should be held liable for warning consumers of risks in their drug labels. In a departure from other recent rulings, the highest California court found that a brand-name drug manufacturer's duty to warn consumers does extend to a generic, but only because federal regulations currently require generic drugs to carr...
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    Updated: New Drug Approvals for FDA: 2017 Hits 21-Year High

    The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies approved this year) has now topped the all-time high of NMEs approved in any year except 1996. But the record number of approvals comes as experts, including CDER Director Janet Woodcock, have expressed reservations about tracking NME approvals like a horse race, or compari...
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    GAO: Retail Drug Price Expenditures Have Nearly Doubled Since 1990s

    The US Government Accountability Office (GAO) on Tuesday released a new report on the pharmaceutical industry's sales and expenses related to research and development (R&D), noting that the amount of money people spend on prescription drugs has nearly doubled since the 1990s, mostly because of brand-name drugs. Retail prescription drug expenditures were estimated to account for about 12% of total personal health care service spending in the US in 2015, up from abou...
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    Senate, House Agree to Cut Orphan Drug Research Credit in Half in Tax Bill

    Members of the House-Senate Conference Committee discussing the GOP's tax overhaul plan on Friday released the final text of the bill, which would reduce the rare disease research tax credits biopharma companies can claim by half. Currently, companies can claim a 50% tax credit for qualified clinical testing expenses incurred in testing certain drugs for rare diseases or conditions, generally referred to as "orphan drugs," affecting fewer than 200,000 persons in th...
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    FDA to Pharma Firms: Update or Certify Drug Listings by End of Month

    • 14 December 2017
    To ensure the National Drug Code directory is accurate, the US Food and Drug Administration (FDA) on Thursday sent a reminder to pharmaceutical companies that 31 December 2017 is the deadline by which the firms must update or certify their drug listings with FDA via electronic format. This applies to drug listings that were not initially listed or updated during the current calendar year and is the first deadline of the annual certification requirement under Part ...
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    Updated: Generic Drug Monthly Dashboard: FDA Adds New Metrics

    The US Food and Drug Administration (FDA) last month began releasing new information a monthly basis related to generic drugs. Whereas in previous years, the agency released monthly statistics on 12 different categories related to FDA’s review of abbreviated new drug applications (ANDAs), now the agency releases monthly data on 30 different categories. The new categories will shine a light on metrics where the generics industry has struggled in recent years, like...
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    FDA Finalizes Guidance on Promotional Drug Labeling and Ads

    The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs. FDA said it received one comment on the revised draft guidance, and in addition to a title change and editorial changes made primarily for clarification, the guidance has been revised to clarify certain concepts discussed in the revised dr...
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    HHS Secretary Nominee Azar: Top Priority is Drug Prices

    The Senate Health, Education, Labor and Pensions Committee hearing on Wednesday grilled President Donald Trump's HHS secretary nominee and former Eli Lilly executive Alex Azar on drug prices, and he vowed that the issue would be his top priority. Sens. Rand Paul (R-KY), Elizabeth Warren (D-MA), Tammy Baldwin (D-WI), Maggie Hassan (D-NH) and others questioned Azar on how he would oversee an industry that he used to work for. "I don't have pharma's policy agenda," A...
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    IGDRP Offers Guidance for Quality Assessors on Drug Substances

    The International Generic Drug Regulators Programme (IGDRP) on Tuesday released guidance finalized in June to help regulatory agencies’ quality assessors review technical information on active substances. Initially drafted by regulators from Australia, Canada, Singapore and Switzerland, the document provides assistance to quality assessors in reviewing the technical information contained in the Quality Module (Module 3) of Active Substance Master Files (ASMFs)/Drug...
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    FDA Issues Delayed DSCSA Grandfathering Guidance

    The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing its policy for when packages and homogenous cases of drugs without a product identifier are grandfathered from certain provisions of the Drug Supply Chain Security Act (DSCSA). While the guidance comes two years after the deadline set by the DSCSA and on the same day that requirements for manufacturers to begin affixing or imprinting product identifiers on packages and homogenous cases ...