FDA Week - 07/20/2018

HHS Reverses Course On Importation, Leaves Drug Industry Reeling

FDA sent shock waves through the pharmaceutical industry Thursday (July 19) by announcing it will study how to import drugs as a response to price spikes.

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Gottlieb: Draft Guide Will Expand Nonprescription Drug Space, Lower Cost

FDA, in a bid to expand use of nonprescription drugs, issued a draft guidance Tuesday (July 17) that proposes two new ways sponsors could demonstrate the safety and effectiveness of nonprescription drugs: providing supplemental information about a drug beyond what is included on the drug facts label (DFL) and requiring consumers meet certain criteria before being allowed to purchase the product.

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Gottlieb: FDA, CMS Eye Reimbursement Changes To Stem Drug Shortages

FDA, through its Drug Shortages Task Force, will work with CMS to revamp reimbursement policies for critical access drugs, especially sterile injectables, to incentivize manufacturers to invest in and modernize their manufacturing processes and spur development of critical access drugs, FDA Commissioner Scott Gottlieb said during a policy summit on Tuesday (July 17).

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FDA Biosimilar Action Plan Mostly Expands On Existing Initiatives

FDA released a long-awaited Biosimilars Action Plan Wednesday (July 18) that promises new development tools for biosimilars makers, additional educational resources and a public hearing dedicated to biosimilar competition, among other initiatives.

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Gottlieb: FDA To Dive Into Debate On Whether Non-Dairy Products Are Milk

FDA commissioner Scott Gottlieb said his agency will soon open a docket to receive public comment on whether non-dairy products can be marketed as milk, stepping into a heated debate between the dairy industry and those marketing non-dairy milk.

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House Passes Legislation To Reauthorize FDA Animal Drug User Fees

The House passed via voice vote on Monday (July 16) legislation to reauthorize FDA's animal drug and animal generic drug user fee programs.

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House Passes OTC Monograph Reform Bill With 18 Months Exclusivity

The House on Monday (July 16) passed an over-the-counter (OTC) monograph reform bill by voice vote that would amend FDA's OTC drug review process, set in place a user fee system known as OMUFA and grant 18 months of exclusivity to makers of innovative OTC drugs.

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FDA To Hold Scientific Conference On Opioid And Nicotine Misuse, Abuse

FDA will hold a two-day scientific conference in September to discuss how sex and gender influence opioid and tobacco misuse and abuse, the agency announced in the Federal Register Friday (July 13).

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FDA Backtracks On Contentious Interchangeability Study Requirement

FDA has listened to biosimilar maker’s complaints and is considering allowing biosimilar developers to use non-U.S. based samples when conducting the studies necessary for FDA-approval, FDA Commissioner Scott Gottlieb revealed Tuesday (July 17).

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FTC Clashes With FDA Over Biosimilar Policies

The Federal Trade Commission is renewing calls for FDA to reverse course on biosimilar naming, and is siding with biosimilar makers' arguments they should be free to test their products using samples marketed outside of the United States.

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FDA Approves First Cancer Drug Through Pilot Review Programs

FDA approved new uses of a cancer drug using two new pilot review programs that aim to streamline the review of cancer drugs and improve the standards for evaluating safety and efficacy, the agency announced Wednesday (July 18).

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Waxman, Hatch Square Off Over The Impact Of The IPR System

The two namesakes of the generic drug pathway law are at odds over the impact of the inter partes review system on the generic drug market.

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FDA Week - 07/20/2018