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Topic: FDA & Food Safety

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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 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 The final guidance comes almost a year after FDA issued a similar draft guidance on the topic. As with the draft guidance, industry remains concerned about … Continue reading

Sugar, Salt and Fat : the Usual Suspects Targeted by Health Canada’s Proposed Mandatory Front-Of-Package Labelling System

Health Canada is contemplating mandatory front-of-package (FOP) labelling for prepackaged foods high in “nutrients of public concern”, namely sugars, sodium and saturated fat. This is one of the key initiatives put forward by Health Canada as part of its Health Eating Strategy, announced on October 24, 2016. A public consultation was launched on November 14, … 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

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

Australia: Regulator considers permitting the sale of food derived from low THC hemp seeds

Food Standards Australia New Zealand (FSANZ) is calling for submissions in response to its draft variation of the Food Standards Code that would permit the sale of foods derived from low tetrahydrocannbinol (THC) hemp.  The proposal follows a request by the Australia and New Zealand Ministerial Forum on Food Regulation (Forum) for FSANZ to consider … Continue reading

Senate agriculture committee reaches deal on national GMO labeling bill

On June 23, 2016, the Senate Agriculture Committee agreed to a bipartisan deal that would set a national standard for GMO labeling. The National Bioengineered Food Disclosure Standard would amend The Agricultural Marketing Act of 1946 by setting forth mandatory disclosure requirements for GMO food products, while providing a variety of options to the industry … Continue reading

U.S. Food and Drug Administration announces new partnership with Canadian Food Inspection Agency on food safety

Summary On May 4, 2016, the U.S. Food and Drug Administration (FDA) signed a “systems recognition arrangement” with the Canadian Food Inspection Agency (CFIA) and Health Canada recognizing the comparability of the U.S. and Canadian food safety systems. This is only the second time that the FDA has recognized a foreign food safety system as … Continue reading

FDA draft guidance to assist CMS with coverage decisions for Medicare payment

On June 1, 2016, the US Food and Drug Administration (FDA) published in the Federal Register (81 Federal Register 35032) a draft guidance for sponsors, clinical investigators, industry, IRBs, and FDA staff regarding categorization of Investigational Device Exemption (IDE) devices as either a Category A or Category B device to assist the Centers for Medicare and … Continue reading

FDA issues final FSMA implementing rule

The 7th and final Food Safety Modernization Act (FSMA) implementing rule is finally here and most companies will have three years to comply.  On May 26, 2016, the FDA finalized the Mitigation Strategies to Protect Food Against Intentional Adulteration rule. The effective date of the rule is May 27, 2016, the date of the rule’s … Continue reading

Australia – nicotine and therapeutic goods

A recent Australian case (http://www.austlii.edu.au/au/cases/cth/FCA/2016/394.html) has touched on the tricky area of nicotine containing products, this time in the guise of product known as the Voke Inhalator, which contained 0.43mg of nicotine in a pressurised inhalation can.  The supplier of the product was seeking to register the product as an OTC product, but our regulator, … Continue reading

Times, they are a-changin’ – new country of origin food labeling system effective 1 July 2016

Summary From 1  July 2016, new country of origin labeling requirements will become a reality in Australia, with a new food labeling system commencing under the Australian Consumer Law. The implementation of the new system will have a two year transition period. From 1 July 2018, the new system will be mandatory and something which … Continue reading

FDA warns of potential link between antimalware and medical device failure

On February 8, 2016, the U.S. Food and Drug Administration (FDA) issued a Product Problem Report concerning the following device: Merge Hemo Programmable Diagnostic Computer, manufactured by Merge Healthcare. The Merge Hemo device monitors, measures and records physiological data from patients undergoing cardiac catheterization procedures and transfers this data to a monitoring station that runs … Continue reading

Australia: Victoria creates new medical cannabis regime – children with epilepsy first to have access

The use of cannabis for restricted medical purposes is set to be legalised in Victoria following the passing of the Access to Medicinal Cannabis Bill 2015.  The Bill creates a new legal regime that regulates the cultivation, manufacture and supply of cannabis in Victoria, and allows for specified categories of patients to have access to … Continue reading

FDA issues Data Integrity Guidance under CGMP

Increasing concerns about data integrity in the pharmaceutical industry have prompted the U.S. Food and Drug Administration (“FDA”) to release Draft Guidance addressing the issue as it relates to current good manufacturing practices (cGMP) for pharmaceutical companies. The Draft Guidance – titled Data Integrity and Compliance with CGMP, Guidance for Industry – is framed a … Continue reading

FDA establishes bright-line recommendations for human drug compounding

On April 15, 2016, the U.S. Food and Drug Administration (FDA) released three draft guidance documents addressing human drug compounding under the Federal Food Drug, and Cosmetic Act (FDCA). FDA issued new policies concerning the prescription requirement under section 503A of the FDCA, human drug compounding in hospitals and health systems, and the facility definition … Continue reading
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