Draft Guidance

News & Analysis as of

FDA Issues New Draft Guidance: New Dietary Ingredient Notifications and Related Issues

Dietary supplements are big business. A recent estimate pegs the U.S. market for dietary supplements at over $35 billion annually. The U.S. Food and Drug Administration (FDA) estimates the number of dietary supplements to be...more

AGG Food and Drug Newsletter - August 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

When Is a Software Change Really a Change that Requires FDA Review?: When to Submit a 510(k) for a Software Change to an Existing...

On the same day the Food and Drug Administration issued its revised draft guidance document on when to submit a new 510(k) premarket notification for an existing medical device, it released a similar document specific to...more

FDA Issues Draft Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

On August 8, 2016, the U.S. Food and Drug Administration (FDA) issued draft guidance on the important topic of deciding when to submit a new 510(k) premarket notification application (510(k)) for a change to an existing...more

European Commission Publishes Draft Regulation on Geo-Blocking – Will It Unblock ECommerce Across the EU?

As part of the Commission’s Digital Single Market initiative, the European Commission has published a draft Regulation aimed at preventing traders from discriminating against customers based on nationality or location. The...more

FDA Releases Revised Guidance on Device Modification Policy

FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft...more

FDA and OHRP Issue Joint Draft Guidance on IRB Written Procedures

On August 2, 2016, the US Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) jointly issued draft guidance concerning Institutional Review Board (IRB) written procedures. The guidance...more

When It’s Time to Change, You’ve Got to Rearrange: FDA Issues Draft Guidance on When Changes to an Existing Medical Device...

Many of us remember the classic 1972 Brady Bunch song, “Time to Change,” when Peter Brady sings (as his voice cracks), “When It’s Time to Change, You’ve Got to Rearrange,” channeling its inner Brady, the Food and Drug...more

FDA Issues Proposed Guidance for Changes to Medical Device Software

The U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices. The proposed guidance relates to requirements for submitting medical device software...more

New FDA Draft Guidance on Benefit-Risk Factors Affecting Medical Device Compliance and Enforcement

In June, the U.S. Food and Drug Administration released draft guidance to clarify the benefit and risk factors it may consider in compliance and enforcement actions involving medical devices. Medical device manufacturers...more

FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices

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 determine whether a new premarket notification (510(k)) is required upon...more

King & Spalding Lawyers Discuss The Regulatory Landscape At Medical Device Cybersecurity Risk Mitigation Conference

On July 25 and 26, 2016, industry stakeholders assembled in Arlington, Virginia, to participate in the Medical Device Cybersecurity Risk Mitigation Conference sponsored by Q1 Productions. The conference focused on the...more

CEQ Issues Final Greenhouse Gas Guidance Directing Federal Agencies to Consider Climate Change in their NEPA Reviews

On August 2, 2016, the White House Council on Environmental Quality (“CEQ”) published a final version of its guidance to federal agencies requiring the consideration of greenhouse gas (“GHG”) emissions and effects on climate...more

FDA Issues Guidance on Use of Public Human Genetic Variant Databases and Their Use in Personalized Medicine

Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development of personalized or precision medicine. Analysis of whole genomes is providing...more

FDA Issues New Draft Guidance Requiring Modifications to Medical Device Tracking Labels

The Food and Drug Administration released draft guidance last week revealing its intent to better track medical devices, from pacemakers to condoms, through an amendment to its 2013 “UDI (unique device identifier) Rule”. The...more

FDA Regulatory and Compliance Monthly Recap — July 2016

FDA publishes draft guidance outlining conflict-of-interest rules for advisory committee members - The draft guidance describes how the agency determines whether members with appearance issues may be allowed to...more

SEC Proposes Business Continuity and Transition Plan Requirements for Investment Advisers; Staff Issues Guidance for Registered...

On June 28, 2016, the US Securities and Exchange Commission (SEC) proposed new Rule 206(4)-4 (Proposed Rule) under the Investment Advisers Act of 1940, as amended (Advisers Act) and also proposed amendments to certain...more

FDA Issues Draft Guidance To Streamline Regulatory Oversight Of NGS-Based Tests For Diagnosing Germline Diseases

Personalized or Precision Medicine needs reliable and accurate diagnostic tests to guide clinical intervention and treatment decisions. Traditional testing of germline variants is site-specific and therefore only provides...more

U.S. EPA Finds Greenhouse Gas Emissions from Aircraft Endanger Public Health—a First Step in Adoption of New ICAO Standards

The International Civil Aviation Organization (ICAO) released a draft rule in February of this year proposing a new standard for reducing GHG emissions in new and in-production commercial aircraft. In the wake of the proposed...more

FDA Releases Draft Guidance for Unique Device Identifiers

The FDA has just released draft guidance for unique device identifiers (UDIs) tracking medical devices from their manufacturers to the end users. Specifically, the FDA is providing guidance to device the content and form of...more

FDA Issues Draft Guidance as Part of Precision Medicine Initiative

The two draft guidance documents are intended to streamline the review of next generation sequencing-based tests. On July 8, the US Food and Drug Administration (FDA or Agency) issued two draft guidance documents...more

FDA’s new Next Generation Sequencing Draft Guidance leaves fundamental questions unanswered: key points

The Food and Drug Administration has released a 25-page Draft Guidance document addressing FDA oversight of certain applications of Next Generation Sequencing (NGS)-based technology. The Draft Guidance - "Use of Standards in...more

Next-Generation Sequencing: FDA Issues New Guidance for Genetic Tests

On July 6, 2016, the U.S. Food and Drug Administration (“FDA” or “Agency”) released the following two draft guidance documents on the oversight of next-generation sequencing (“NGS”) tests...more

FDA Releases Draft Guidance on Codevelopment of Therapeutic Products and Screening Tests

On July 14, 2016, the U.S. Food and Drug Administration (the “FDA”) released draft guidance on the codevelopment of therapeutic products (such as pharmaceuticals) and companion tests that are used to determine if the...more

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance...more

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