Michael Ryan

Michael Ryan

McDermott Will & Emery

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FDA 2016 Year in Review

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

2/10/2017 - 510(k) RTA Biologics Clinical Trials Cybersecurity FDA General Wellness Devices Laboratories Medical Devices Pharmacies REMS Software

FDA Clarifies “Intended Use” for Drugs, Devices, and Tobacco Products

In its Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” (Final Rule), FDA codifies its long-standing...more

2/6/2017 - FDA Manufacturers Regulatory Oversight Tobacco Tobacco Regulations

FDA Issues Draft Guidance on Payor Communications

Shortly after the recently enacted, bipartisan 21st Century Cures Act, which revised and expanded the extent to which specific health care economic information (HCEI) may be disseminated to certain stakeholders, and comes...more

2/2/2017 - Draft Guidance Evidentiary Standards FDA HCEI Manufacturers Pharmaceutical Industry

FDA Issues Draft Guidance on Communications That Are Consistent with FDA-Required Labeling

This On the Subject reviews the US Food and Drug Administration’s recently released draft guidance on promotional materials and communications that are consistent with FDA-required labeling. The guidance provides a...more

1/27/2017 - Draft Guidance FDA Labeling Manufacturers Pharmaceutical Industry

FDA Outlines Substantially Revised ‘Possible Approach’ to the Regulation of Laboratory-Developed Tests

On January 13, 2017, the US Food and Drug Administration (FDA) posted a “discussion paper” in which the agency outlines a substantially revised “possible approach” to the oversight of laboratory-developed tests (LDTs). The...more

1/26/2017 - Adverse Events Analytics Draft Guidance FDA Laboratory Developed Tests Medical Devices

21st Century Cures: Food and Drug Administration (FDA) Drug Provisions

The 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment and facilitating innovation review and...more

1/6/2017 - 21st Century Cures Act FDA Healthcare Manufacturers Pharmaceutical Industry

21st Century Cures: Examining Medical Device Provisions

The 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment and facilitating innovation review and...more

12/21/2016 - 21st Century Cures Act FDA Manufacturers Medical Devices Transparency

21st Century Cures: Examining Provisions for Streamlining FDA Regulations for Clinical Research in Title III

The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more

12/16/2016 - 21st Century Cures Initiative Clinical Trials FDA HHS

FDA Hosts Public Meeting on Off-Label Communications

The US Food and Drug Administration (FDA) recently held a two-day public meeting on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (off-label communications), which offered...more

11/17/2016 - FDA Manufacturers Medical Devices Off-Label Use Pharmaceutical Industry Public Meetings

CMS, FDA Parallel Review Program for Medical Devices Extended Indefinitely

On October 24, 2016, the US Food and Drug Administration and the Centers for Medicare & Medicaid Services announced the full implementation and indefinite extension of the Program for Parallel Review of Medical Devices (the...more

10/31/2016 - CMS FDA Medicaid Medical Devices Medicare

FDA Finalizes Rule Governing Establishment Registration and Listing for Human Drugs

On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more

10/4/2016 - Animal Drugs Biologics FDA FDASIA FDCA Final Rules Pharmaceutical Industry Proposed Rules

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

9/29/2016 - Biologics Draft Guidance Drug Treatment FDA Pharmaceutical Industry Public Comment REMS Safety Precautions

FDA Extends Deadline for Removal of NDC and NHRIC Numbers from Device Labeling and Packaging

On August 30, 2016, the US Food and Drug Administration (FDA) published final guidance in which the agency announced it does not intend to enforce its prohibition against the inclusion of National Health Related Item Code...more

9/20/2016 - FDA Final Guidance Manufacturers Medical Devices Pharmaceutical Industry Product Labels Unique Device Identifiers

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

8/10/2016 - 510(k) RTA Draft Guidance FDA Medical Devices Modification Software

FDA Finalizes Guidance on Low Risk General Wellness Devices

On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory...more

8/4/2016 - FDA Final Guidance General Wellness Devices Medical Devices

FDA Releases Draft Guidance for Manufacturers on Dissemination of Patient Data from Medical Devices

On June 9, 2016, the US Food and Drug Administration (FDA) published draft guidance outlining considerations for the “appropriate and responsible” dissemination of individualized medical device data from device manufacturers...more

6/22/2016 - Draft Guidance FDA Manufacturers Mobile Health Apps Patient Rights Right of Access

Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws

This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps...more

4/21/2016 - Breach Notification Rule FDCA FTC HIPAA Mobile Health Apps

FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness

At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel...more

2/18/2016 - Big Data Biologics Center for Drug Evaluation and Research (CDER) Databases Electronic Medical Records FDA Medical Devices Prescription Drugs

FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more

1/28/2016 - Cybersecurity Draft Guidance FDA Health Care Providers Health Information Technologies Medical Devices Patient Safety Risk Management

FDA Releases Long-Awaited Biological Naming Draft Guidance and Proposed Rule

On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more

9/10/2015 - Biologics Biosimilars Comment Period Draft Guidance Drug Safety FDA Federal Register Pharmaceutical Industry Prescription Drugs Proposed Regulation Public Health Service Act World Health Organization

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

4/30/2015 - Clinical Trials FDA Investigational Device Exemptions Medical Devices Premarket Approval Applications

FDA Issues Draft Guidance on Use of Electronic Informed Consent in Clinical Trials

On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more

3/26/2015 - Clinical Trials FDA HHS Informed Consent Medical Research Pharmaceutical Industry Scientific Research

Pomegranate Health Benefit Claims Were False, Misleading - POM Wonderful, LLC, et al. v. Federal Trade Commission

In an opinion addressing the amount and type of scientific evidence required to substantiate disease treatment and prevention claims, the U.S. Court of Appeals for the District of Columbia upheld the Federal Trade...more

3/19/2015 - Advertising Clinical Trials False Advertising FTC POM Wonderful

FDA Will Not Enforce Regulatory Controls for Medical Device Data Systems and Two Other Health IT Devices

In a move certain to please developers of health information technology (IT) products, on February 6, 2015, the U.S. Food and Drug Administration (FDA) posted final guidance announcing its intent to exercise enforcement...more

2/12/2015 - FDA Final Guidance Healthcare Medical Device Accessories Medical Devices

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