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Results: 1-10 of 87

FDA publishes draft guidance on statistical approaches to assessing analytical similarity of biosimilars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The FDA issued a draft guidance document to assist with the marketing application submission for biosimilar products.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 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 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 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 holds off on enforcement of product identifier requirements for one year
  • Loeb & Loeb LLP
  • USA
  • July 31 2017

The FDA issued draft guidance outlining its compliance policy for product identifier requirements and indicated that it doesn’t plan to take action


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


Senate, House committees advance user fee reauthorizations as Trump seeks renegotiation
  • Loeb & Loeb LLP
  • USA
  • May 30 2017

Both the House E&C subcommittee and Senate HELP committee advanced legislation to reauthorize the user fees for the next five years, but President