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FDA publishes draft guidance on statistical approaches to assessing analytical similarity of biosimilars
  • Loeb & Loeb LLP
  • USA
  • October 30 2017

The FDA issued a draft guidance document to assist with the marketing application submission for biosimilar products. As part of the application


FDA updates guidance on Center for Devices and Radiological Health (CDRH) appeals process
  • Loeb & Loeb LLP
  • USA
  • October 30 2017

The Guidance Notes that the documentation and review procedures required by Section 517A of the FD&C Act apply only to “significant decisions” (or


FDA finalizes clarifying process for classifying combination products as drugs, biologics or medical devices
  • Loeb & Loeb LLP
  • USA
  • October 30 2017

The FDA’s finalized guidance places a particular focus on cases in which a combination product may be classified as a drug or device. The document


FDA offers final guidance for drugmakers looking to participate in emerging manufacturing technologies program
  • Loeb & Loeb LLP
  • USA
  • October 30 2017

The FDA issued final guidance aimed at providing drug companies with the criteria for involvement in the agency’s Emerging Technology Program. The


FDA Regulatory and Compliance Monthly Recap August 2017
  • Loeb & Loeb LLP
  • USA
  • August 31 2017

In its Digital Health Innovation Action Plan, the agency outlines the guidance documents it plans to publish as it looks to implement a new approach


FDA Regulatory and Compliance Monthly Recap June 2017
  • Loeb & Loeb LLP
  • USA
  • June 10 2017

The cost estimate, based on the Senate’s user fee reauthorization legislation, reflects $9 billion in user fees from 2018 to 2022. It predicts that


Gottlieb confirmed as FDA commissioner; signals need to address regulation of generics, biosimilars
  • Loeb & Loeb LLP
  • USA
  • May 30 2017

In a split vote, the Senate confirmed the nomination of Scott Gottlieb as the next head of the FDA. Gottlieb emphasized the need to take action to


Vertical Pharmaceuticals hit with warning letter over deficient PADE reporting
  • Loeb & Loeb LLP
  • USA
  • May 30 2017

The letter takes issues with Vertical's protocols to monitor, receive, evaluate and report postmarketing adverse drug events and raises concerns about


Industry stakeholders offer input on FDA’s draft guidances on off-label communications
  • Loeb & Loeb LLP
  • USA
  • May 30 2017

Industry stakeholders are weighing in on the two draft guidances issued by the FDA outlining how drug and device companies can discuss off-label uses


Industry groups say final rule on intended use establishes unfounded legal standard, call for indefinite stay
  • Loeb & Loeb LLP
  • USA
  • February 27 2017

Citing violations of the APA and what they call the establishment of a "new and unjustified legal standard," a coalition of industry groups is