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Highly Anticipated FDA Draft Guidance Documents on 510(k) Device Modifications Add New Considerations to the Decision-Making Process for Companies
  • Hogan Lovells
  • USA
  • August 11 2016

On August 8, 2016, FDA issued two highly anticipated draft guidance documents, entitled Deciding When to Submit a 510(k) for a Change to an Existing

Marijuana will not be rescheduled in 2016
  • Husch Blackwell LLP
  • USA
  • August 11 2016

The U.S. Drug Enforcement Administration filed documents with the Federal Register on Thursday outlining its denial of petitions to reschedule

FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices
  • McDermott Will & Emery
  • USA
  • August 10 2016

On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff

“Institutional Review Board (IRB) Written Procedures” Draft Guidance and NIH’s “Single IRB Policy” Offer Food for Thought to IRBs Charged with Oversight of Human Subjects Research
  • Hogan Lovells
  • USA
  • August 8 2016

Last week, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) of the U.S. Department of Health and

Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 6
  • Jones Day
  • USA, United Kingdom, European Union
  • August 3 2016

FDA recently released, as a part of President Obama's Precision Medicine Initiative, two draft guidance documents proposing what the Agency is

FDA issues final guidance for general wellness devices
  • Morgan Lewis
  • USA
  • August 1 2016

On July 29, the US Food and Drug Administration (FDA) announced the availability of its guidance document, General Wellness: Policy for Low Risk

FDA’s new Next Generation Sequencing Draft Guidance leaves fundamental questions unanswered: key points
  • DLA Piper
  • USA
  • July 26 2016

The Food and Drug Administration has released a 25-page Draft Guidance document addressing FDA oversight of certain applications of Next Generation

FDA Releases Flurry of Compounding-Related Documents
  • Quarles & Brady LLP
  • USA
  • July 19 2016

Busy, busy, busy! That is the only way to describe the FDA over the past few weeks, issuing multiple draft guidance documents affecting both 503A and

Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 5
  • Jones Day
  • USA
  • July 13 2016

On June 2, 2016, FDA announced the availability of three final guidance documents aimed at simplifying and clarifying expanded access for

FDA draft guidance offers recommendations on how to ensure proper dissemination by manufacturers of patient-specific information derived from medical devices
  • Loeb & Loeb LLP
  • USA
  • June 12 2016

The document clarifies that medical device manufacturers may share patient-specific data from a medical device with the patient using that specific