On March 19, the Food and Drug Administration (FDA) released guidance providing recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic, including COVID-19. The guidance revises and replaces final guidance released in 2012 entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary
Greater than the Sum of Its Parts: FDA Releases Supplemental Draft Completing its Draft Guidance Regarding Protecting Food Against Intentional Adulteration
FDA’s recently released Supplemental Draft Guidance entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry” serves as a substantial supplement to the lengthy Revised Draft Guidance that FDA issued in March 2019 which shares the same title.[1] Once finalized, these guidance documents will together serve to help covered companies comply with
FDA Approves Genetically Engineered Atlantic Salmon as Safe and Effective for Human Food and Releases Related Draft Guidance on Voluntary Labeling
On Thursday, November 19th, the Food & Drug Administration (FDA) announced that it had approved an application for AquAdvantage Salmon, a type of Atlantic Salmon that has been genetically engineered to grow to market size more quickly than other salmon. The agency regulates genetically engineered (GE) animals such as AquAdvantage Salmon under the
FDA Publishes Guidance on Food, Beverage, and Dietary Supplement Additives
On January 14, the Food and Drug Administration (“FDA”) published a guidance document entitled Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements, with the goal of reminding industry: (1) about the Federal Food, Drug and Cosmetic Act’s requirements governing substances added to conventional foods, including beverages; and (2) that those same
FDA Sets 10 ppb Action Level for Inorganic Arsenic in Apple Juice
The Food and Drug Administration (FDA) has issued a draft guidance document entitled Arsenic in Apple Juice: Action Level in which it announces an action level of 10 ppb for inorganic arsenic in apple juice. This action level is consistent with the 10 ppb limit for arsenic set by the Environmental Protection Agency for drinking
FDA Announces Final Rule Banning BPA from Infant Formula Packaging
The Food and Drug Administration (“FDA”) announced last week the publication of a final rule banning bisphenol-A (“BPA”) from use in infant formula packaging – a decision made based on proof of industry abandonment rather than safety concerns. In July 2012, then-U.S. Representative Edward J. Markey filed a food additive petition seeking to amend the
Handy Health Tracking Mobile App…Or Regulated Medical Device?
The use of mobile apps for health purposes has created new questions for users, developers, and regulators regarding the balance between convenience, expanded health care, and public safety. The line between apps that are useful tools for accessing health information and those that are considered medical devices can be unclear but is very important for
DHHS and FDA Officials Respond to Medical Device Mobile Application Regulatory Concerns on Final Day of Hearings
The House Subcommittee on Oversight and Investigations concluded a three-day series of hearings regarding medical device mobile applications (“MMAs”) on Thursday morning. Our posts regarding the first two hearings are here and here. The focus of day three was to hear testimony from key FDA and DHHS officials who have responsibilities relating to MMAs
Day 2 of Medical Device Mobile App Hearings Focuses on Patient Benefits
The Health Subcommittee of the House of Representatives Energy and Commerce Committee held a second day of hearings regarding medical device mobile applications (“MMAs”) on Wednesday. Our post regarding the first day of hearings can be found here. The focus of day two was “Health Information Technologies: How Innovation Benefits Patients.”
The subcommittee heard
IOM Report on Counterfeit Drugs Released
On February 13, 2013, the Institute of Medicine of the National Academies (IOM) released its report Countering the Problem of Falsified and Substandard Drugs. The report identifies causes and recommends strategies to address the problem of substandard and falsified drugs.
The IOM first distinguishes public health concerns of falsified and substandard drugs from the