Vernessa Pollard on Food and Drug Administration (FDA)

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 , FDASIA , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , 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FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

9/29/2016 / Biologics , Draft Guidance , Drug Treatment , Food and Drug Administration (FDA) , Pharmaceutical Industry , Public Comment , REMS , Safety Precautions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 / Final Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry , Product Labels , Unique Device Identifiers

FDA Announces Public Hearing on Off-Label Communications; Registration Deadline October 19, 2016

The US Food and Drug Administration (FDA) will hold a public hearing on November 9 and 10, 2016, to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products (off-label...more

9/20/2016 / First Amendment , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Off-Label Promotion , Pharmaceutical Industry , Public Hearing

FDA and OHRP Issue Joint Draft Guidance on IRB Written Procedures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2, 2016, the US Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) jointly issued draft guidance concerning Institutional Review Board (IRB) written procedures.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

8/15/2016 / Department of Health and Human Services (HHS) , Draft Guidance , Food and Drug Administration (FDA) , Institutional Review Board (IRB) , Office for Human Research Protections (OHRP) , Research and Development

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 , Food and Drug Administration (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 / Final Guidance , Food and Drug Administration (FDA) , General Wellness Devices , Medical Devices

FDA Takes Further Steps to Curb Opioid Abuse

Required Black Box Warnings on Immediate Release Opioids - Closely following on recent efforts undertaken by states and the Centers for Disease Control to curb opioid abuse (review further here and here), the U.S. Food...more

4/1/2016 / Centers for Disease Control and Prevention (CDC) , Drug & Alcohol Abuse , Food and Drug Administration (FDA) , Prescription Drugs , Warning Labels

Vernessa Pollard

McDermott Will & Schulte

Popular Topics by This Author

Latest Posts › Food and Drug Administration (FDA)