Tag archives: FDA

U.S. Senate Republican leadership decides against full Senate vote on Graham-Cassidy ACA repeal and replace legislation; HHS Secretary Tom Price resigns under pressure from the White House

On Tuesday, September 26, Senate Republican leadership decided not to hold a full Senate vote on the Graham-Cassidy Affordable Care Act (ACA) repeal and replace legislation. The previous day, Monday, September 25, the Senate Finance Committee held a hearing on the Graham-Cassidy bill. Following the hearing, Senator Susan Collins (R-ME) announced her opposition to the … Continue reading

FDA extends compliance date for Nutrition Facts Label rule

On June 13, 2017, the US Food and Drug Administration (“FDA”) announced that it was extending the compliance date for the Nutrition Facts Label rule. The FDA will provide the final details regarding the extension of the compliance date through a Federal Register Notice that it will publish at a later date. The FDA released … Continue reading

FDA / EMA parallel scientific advice principles published

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) recently released an updated “General Principles” statement regarding the agencies’ parallel scientific advice (PSA) program for human medical products. The PSA program provides scientific advice and protocol assistance in parallel to sponsors. “Sponsor” refers to: in the US, the sponsor of an Investigational … Continue reading

FDA and NIH finalize clinical trial protocol template

On May 2, 2017, the U.S. Food and Drug Administration (“FDA”) and The National Institutes of Health (“NIH”), through the NIH-FDA Joint Leadership Council, released the final version of a clinical trial protocol template in an effort to assist investigators conducting clinical trials and to create cost and time efficiencies in the medical product development … Continue reading

FDA announces plans to create a centralized digital health unit

The U.S. Food and Drug Administration (“FDA”) has announced plans to create a centralized digital health unit within the Center for Devices and Radiological Health (“CDRH”), further supporting CDRH’s 2016-2017 vision to establish a more robust national evaluation system for medical devices.  FDA will form the new digital health unit within CDRH’s Office of the … Continue reading

FDA extends compliance date for menu labeling rule

On May 1, 2017, the FDA announced that it would issue an interim final rule that would extend the compliance date for the menu labeling rule to May 7, 2018. The original compliance date was just four days later on May 5, 2017. The menu labeling rule requires restaurants and similar retail food establishments that … Continue reading

Retailers petition FDA to revise menu labeling rule

On April 5, 2017, the National Grocers Association (“NGA”) and National Association of Convenience Stores (“NACS”) filed a citizen petition with the U.S. Food and Drug Administration (“FDA”). The citizen petition (“petition”) urged the FDA to halt and consider changes to its final menu labeling rule (“final rule”), which is set to take effect on … Continue reading

CBO releases assessment on American Health Care Act; FDA fees double under President Trump budget proposal

On Monday, March 13, 2017, the Congressional Budget Office (CBO) and the Joint Committee on Taxation (JCT) released an assessment on the impact of the American Health Care Act (AHCA), the Republican proposed legislation to repeal and replace the Affordable Care Act. The assessment evaluated the impact of the AHCA on the federal budget and … Continue reading

Just before inauguration, FDA issues memo to address off-label promotion

On January 18, 2017, two days before President Trump took office, the US Food and Drug Administration (FDA) issued two pieces of draft guidance for off-label communications. The first addresses communications with payors and formulary committees, and the second outlines “Questions and Answers” about how FDA evaluates communications about information not contained in approved labels … Continue reading

Biologics: what’s in a name? Health Canada and EMA take a different approach from FDA

Last week the US Food and Drug Administration (“FDA”) provided guidance on the Nonproprietary Naming of Biological Products. Each biologic, whether originator, related product or subsequent entry (biosimilar) will now be given a non-proprietary name comprised of a core name and a meaningless four-letter suffix. This is an important divergence from the practice in Canada … Continue reading

FDA approves opioid drug Arymo ER for chronic pain management

On January 9, 2017, the US Food and Drug Administration (“FDA”) approved opioid drug Arymo ER (morphine sulfate) manufactured by Egalet US, Inc. (“Egalet”) for use in the management of pain severe enough to require long-term opioid treatment, and where alternative treatment options are inadequate. In its approval, FDA explains that typical post-marketing surveillance of adverse … Continue reading

FDA issues final guidance on postmarket medical device cybersecurity

On December 28, 2016, the U.S. Food and Drug Administration (FDA) released final guidance on the management of cybersecurity vulnerabilities for marketed and distributed medical devices.  The guidance establishes a risk-based approach for the reporting of medical device cybersecurity vulnerabilities to the FDA. The FDA guidance reflects the agency’s concerns that cybersecurity vulnerabilities in networked … Continue reading

FDA enforcement spike targets drug promotions

The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) focused its end-of-year enforcement efforts on drug manufacturers’ promotions on tv, social media ads, and electronic promotion efforts. The OPDP issued in December six of its eleven total enforcement letters for 2016.  The eleven disciplinary letters represents a small spike from previous years’ … Continue reading

FDA proposes new research on social media promotion of prescription drugs

The U.S. Food and Drug Administration (“FDA”) regulates the use of social media to disseminate information about prescription drugs and medical devices. Our firm sister blog, the Social Media Law Bulletin, previously covered the social media guidance released by the FDA in 2014, and a sampling of Warning and Untitled Letters that the FDA has issued to … Continue reading

FDA finalizes guidance on medical device safety

The Food and Drug Administration (“FDA”) released its final guidance on medical device safety on December 14, 2016, titled “Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals).” The final guidance comes almost a year after FDA issued a similar draft guidance on the topic. As with the draft guidance, industry remains concerned about … Continue reading

FDA delays lab developed test guidance

The US Food and Drug Administration (“FDA”) announced on November 18, 2016 that it will not release a final guidance to regulate laboratory developed tests (“LDTs”), in vitro diagnostic tests designed, manufactured, and used within a single laboratory. The announcement marks a significant reversal from the previous positions of the Obama administration, FDA, and specifically, Dr. … Continue reading

No monetary penalties for manufacturer providing physicians with free vaccine refrigeration storage system

In an Advisory Opinion issued on September 23, 2016, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) announced that  it would not impose administrative sanctions against the manufacturer of a vaccine refrigeration system (the “Requestor”) for providing the devices to physicians without charge.  This development comes at a critical time … Continue reading

Ninth circuit upholds conviction for physician for re-using single use devices

Last week, the Ninth Circuit affirmed a physician’s conviction for conspiracy to distribute an adulterated device with intent to defraud or mislead in violation of Section 331(k) of the federal Food, Drug and Cosmetic Act (FDCA). The physician – who dubbed his own practice “The McDonald’s of Urology” because of the high volume of patients … Continue reading

FDA now demands its strongest black box warnings for certain opioid and other drugs

On August 31, 2016, the U.S. Food and Drug Administration (“FDA”) announced class-wide drug labeling changes aimed at providing better information to health care providers and patients. FDA’s guidance warns of the risks associated with combined use of certain opioid medicines and benzodiazepines. FDA prepared a Drug Safety Communication directed to health care professionals and … Continue reading
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