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FDA Finalizes Guidance on Medical Product Communications that are Consistent with Approved Labeling
  • Loeb & Loeb LLP
  • USA
  • June 26 2018

Earlier this month, FDA issued a final guidance titled “Medical Product Communications that are Consistent with the FDA-Required Labeling - Questions


FDA Regulatory and Compliance Monthly Recap June 2018
  • Loeb & Loeb LLP
  • USA
  • June 10 2018

In line with the HHS blueprint to lower drug prices and link payments for drugs to their value, the FDA finalized guidance to provide drug makers with


FDA Regulatory and Compliance Monthly Recap May 2018
  • Loeb & Loeb LLP
  • USA
  • May 6 2018

In the FDA’s Drug Safety Priorities Report 2017, CDER Director Janet Woodcock said drug safety requires an interdisciplinary approach with proactive


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FDA publishes draft guidance on statistical approaches to assessing analytical similarity of biosimilars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The FDA issued a draft guidance document to assist with the marketing application submission for biosimilar products.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 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The FDA issued draft guidance outlining its compliance policy for product identifier requirements and indicated that it doesn’t plan to take action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