The FDA revised its guidance on postmarket adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing COVID-19 pandemic. The FDA acknowledges that companies, and the agency, itself, may be hit with workforce shortages during a pandemic at the same time that adverse event reporting for products deployed for the pandemic may increase ...
FDA announced it will open a public docket and hold an Immunology Devices Panel meeting to deliberate the potential for patients who receive medical device implants that contain select metal or metal alloys to develop immune and inflammatory reactions. The panel may provide input on scientific information the FDA should consider as part of premarket review and postmarket surveillance of metal-containing implants and dental amalgams ...
FDA Warns Consumers About Unauthorized Fraudulent COVID-19 Products.The FDA issued a Consumer Update advising consumers to be beware of fraudulent coronavirus tests, vaccines and treatments. The FDA has seen unauthorized fraudulent test kits for COVID-19 being sold online. Currently, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19 ...
Acting Food and Drug Administration (FDA) Commissioner Norman Sharpless has issued a statement warning Americans to stop using vaping products that emit THC until further testing can be done. Federal and state public health agencies, including the FDA, have been investigating an unprecedented wave of 1,000-plus cases of severe lung injuries and deaths among consumers who claimed they used vaping products containing THC, nicotine, or both ...
Key Notes FDA announces flexible approach to enforcement of Nutrition and Supplement Facts labeling requirements for small food manufacturers and manufacturers of packaging for single-ingredient sugars, in part due to the impacts of COVID-19. The FDA adopted final rules updating the Nutrition and Supplement Facts1 labeling requirements (the “Rules”) that are effective on Jan ...
On March 27, 2020, President Donald Trump signed into law a $2 trillion emergency relief bill to ease the economic impact of coronavirus (COVID-19) and support response efforts. The CARES Act[1] included an allocation of $80 million in funding to the U.S. Food and Drug Administration (FDA) to continue its COVID-19 response efforts. The additional agency funding will be used, in part, for the development of medical countermeasures and vaccines ...
This year marks the 30th anniversary of the passage of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act). Considered to be one of the most successful pieces of legislation ever enacted, the Hatch-Waxman Amendments created the modern generic drug industry, which is responsible for dramatically increasing the availabilty of low-cost generic drugs and saving the U.S. healthcare system billions of dollars ...
On Tuesday, the United States Court of Appeals for the Third Circuit departed from opinions issued by the Fourth and Ninth Circuits in ruling that violations of the FDCPA begin to run when the violation occurs. In Rotkiske v. Klemm, et al., plaintiff Rotkiske sued a law firm that, in 2009, had obtained a default judgment against him. The law firm moved to dismiss the FDCPA claim, alleging it was untimely ...
Here are select February 2013 rulings of the Supreme Court of the Philippines on criminal law and procedure: 1. REVISED PENAL CODE Conspiracy; joint purpose and design. Conspiracy may be deduced from the mode, method, and manner in which the offense was perpetrated; orinferred from the acts of the accused when those acts point to a joint purpose and design, concerted action, and community of interests ...
Here are select February 2013 rulings of the Supreme Court of the Philippines on legal and judicial ethics: Attorney; confidentiality of proceedings against attorneys; exception. Atty. Fortun filed a petition for contempt against respondents for publicizing the disbarment case against him in media. Section 18, Rule 139-B of the Rules of Court states that “proceedings against attorneys shall be private and confidential ...
Here are select February 2013 rulings of the Supreme Court of the Philippines on remedial law:Civil ProcedureActions; cause of action; elements; failure to state a cause of action is ground for dismissal ...
Earlier this summer, the U.S. Court of Appeals for the Federal Circuit issued a split decision in Inserso Corporation v. U.S. that we argued had far-reaching implications for both government contractors and the private bar, relating to timeliness and waiver issues in the bid protest context. The Federal Circuit recently issued another decision, The Boeing Company v. U.S ...
In a split decision with far-reaching implications for both government contractors and the private bar, the U.S. Court of Appeals for the Federal Circuit, in Inserso Corporation v. U.S., recently addressed timeliness and waiver issues in the bid protest context. The facts of this significant case, the majority and dissenting opinions, as well as key takeaways for federal contractors and their attorneys, are discussed below. The Facts The U.S ...
The purposes of this Health Care Alert are to: 1) summarize recently proposed federal regulations which will require physician disclosure of ownership interests in hospitals to patients; 2) remind health care providers of existing Texas laws requiring disclosure of ownership interests and 3) suggest best practices for disclosure of ownership interests ...
On January 8, 2018, the U.S. Court of Appeals for the Federal Circuit issued itsen bancdecision inWi-Fi One, LLC v. Broadcom Corp., Appeal 2015-1944 (Fed. Cir. Jan. 8, 2018) (en banc) holding that Patent Trial and Appeal Board (“PTAB”) time-bar determinations under 35 U.S.C. § 315(b) in aninter partesreview (“IPR”) proceeding are appealable. Theen bancdecision overrules a panel’s earlier decision inAchates Reference Publishing Inc. v. Apple Inc.803 F ...
A recent decision in the Full Federal Court has shown that while manufacturers are generally free to make goods according to a design that is not registered, care must be taken to ensure that those products are branded in a way that distinguishes them from the market leader ...
A trio of federal statutes often referred to collectively as the P&A Acts, which includes the Protection and Advocacy for Individuals with Mental Illness Act (PAIMI), the Developmental Disabilities Assistance and Bill of Rights Act (PADD), and the Protection and Advocacy of Individual Rights Act (PAIR), authorize the creation and operation of a protection and advocacy system (P&A system) to monitor the care of individuals with mental illness and developmental disabilities ...
On June 22, 2020, a US District Court for the Eastern District of California issued a permanent injunction against requiring a Proposition 65 warning on the labels of herbicides containing glyphosate, such as Roundup. In National Association of Wheat Growers, et al. v ...
On March 8, 2024, just days before it was set to take effect, U.S. District Judge J. Campbell Barker of the Eastern District of Texas vacated the National Labor Relations Board’s (“NLRB’s”) recent rule on determining the standard for joint-employer status. The NLRB issued the rule on October 26, 2023. It established a seven-factor analysis, under a two-step test, for determining joint employer status ...
In a recent opinion out of the U.S. District Court for the District of Columbia, U.S. District Court Judge Rudolph Contreras held that the U.S. Department of Health and Human Services (HHS) exceeded its authority when it substantially reduced the amount Medicare pays for 340B-acquired medications ...
