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    Gottlieb: 'End the Shenanigans' on Delaying Generic Drug Competition

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday called to "end the shenanigans" that often delay or restrict generic drug competition. The comment followed Gottlieb's discussion of the ways in which brand-name drug companies can use Risk Evaluation and Mitigation Strategies (REMS) or other tactics to prevent generic companies from purchasing drug product to run bioequivalence or bioavailability studies necessary for approval. Federal...
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    FDA Drafts Guidance on Controlled Correspondence Under GDUFA II

    The US Food and Drug Administration (FDA) on Thursday released draft guidance on the agency’s new commitments related to controlled correspondence under the recently reauthorized Generic Drug User Fee Amendments (GDUFA II). When finalized, the 20-page guidance will replace guidance from September 2015 from GDUFA I. The GDUFA II commitment letter defines complex controlled correspondence as correspondence related to: Evaluation of clinical content Review of bioe...
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    Pay-for-Delay Deals: FTC Notes Continued Decline Since SCOTUS Ruling

    The total number of deals in which brand name drugmakers pay to delay the entry of generic competitors continues to decline, and only 5 of the 170 final settlements in FY 2015 included compensation to the generic and a restriction on generic entry, the Federal Trade Commission (FTC) said in a report released Wednesday. FY 2015 is the second complete year of filings since the Supreme Court decided FTC v. Actavis, Inc. in June 2013, when it found that a branded drug ...
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    Updated: FDA Releases Flurry of New, Revised Drug-Specific Guidance Documents

    The US Food and Drug Administration (FDA) on Thursday released new draft guidances for 32 drugs, including for those companies looking to develop generic versions of Mylan’s EpiPen (epinephrine) alternative Adrenaclick, Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib). On top of the new drafts, FDA released 19 revised guidance documents, including one for companies looking to develop generics of Eli Lilly’s er...
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    Another Record Year for US Generic Drug Approvals in 2017

    The US Food and Drug Administration (FDA) has approved more abbreviated new drug application (ANDA) in 2017 than any other year, according to the latest FY 2017 activities report. The 763 approvals (or 927 approvals and tentative approvals) is 112 more generic approvals than last year , which set the previous record for the highest tally in a year, and 271 more than 2015 and 354 more than in 2014 . And unlike in 2016, when FDA issued a vastly higher number of ...
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    FDA Targets Complex Generic Drugs With New Draft Guidance

    The US Food and Drug Administration (FDA) on Monday kicked off a two-day meeting on modernizing generic drug development and released two new draft guidance documents on complex generic drugs – an area where increasing competition can be difficult. FDA Commissioner Scott Gottlieb spoke at the meeting on Monday morning, highlighting recent moves to establish a list of off-patent drugs that will receive expedited approval if an abbreviated new drug application (AND...
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    Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable'

    A generic drug industry group and several companies have taken issue with recent US Food and Drug Administration (FDA) draft guidance on pre-submission facility correspondence (PFC) that spells out what companies need to do to obtain faster abbreviated new drug application (ANDA) reviews. In June, FDA released the draft guidance noting that it is "critical" for there to be a two-month lead time to determine whether facility inspections will be needed for the 8-mon...
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    Balancing Hatch-Waxman: Stakeholders Weigh in After FDA’s Meeting

    Following a US Food and Drug Administration (FDA) meeting in July on generic drug competition, various stakeholders are offering written comments on reforms FDA and Congress could make to ensure the Hatch-Waxman amendments are not abused. Like others, California Attorney General Xavier Becerra submitted comments calling for pay-for-delay agreement reforms, including legislation to make the deals "presumptively unlawful," reforms to FDA’s citizen petition process a...
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    FDA Aligns With Citizen Petition, Revises Draft Guidance on Pricey Generic Heart Drug

    Manufacturers looking to market generic versions of a heart medicine that has been around since the 18th century and seen its price rise by more than 600% in recent years will have to work with a new revised US Food and Drug Administration (FDA) draft guidance released Tuesday. The revised guidance aligns with a citizen petition filed by Concordia Pharmaceuticals , the manufacturer of the authorized generic version of the drug, known as digoxin (or by t...
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    Some FDA Medical Device, Generic Drug User Fees Spike in FY 2018

    Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) and Medical Device User Fee Amendments of 2017 (MDUFA IV), the US Food and Drug Administration (FDA) will collect significantly higher user fees for some applications than in recent years though how the fees are calculated has been restructured under the two new agreements. For instance, device companies submitting 510(k) applications, which are for devices equivalent to ones already marketed, fees wi...
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    Generic Drugs in 2017: FDA on Track for Most Approvals Ever

    A little more than 10 months into Fiscal Year 2017 and the US Food and Drug Administration (FDA) is on pace to break its record for abbreviated new drug application (ANDA) approvals from last year. According to the latest version of the activities report of the generic drug program , FDA has approved 633 generic drugs in FY 2017, which compares with a total of 651 approvals in FY 2016 . Also a positive: complete responses for generic drugs are down significantl...
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    Report Highlights Cracks in the Market for Generic Competition

    As the US Food and Drug Administration (FDA) looks for ways to boost generic competition, a new working paper published by the National Bureau of Economic Research (NBER) suggests that competition among generic drugmakers slows over time, potentially leading to higher prices for older treatments and drug shortages. The analysis, authored by Ernst Berndt and Stephen Murphy of the Massachusetts Institute of Technology, and Rena Conti from the University of Chicago, reveals...