Last week, the U.S. Food and Drug Administration (FDA) issued guidance for the health care industry, titled “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency ...
On April 6, the Food and Drug Administration (FDA) issued five warning letters chastising companies for their unapproved products related to the novel coronavirus disease 2019 (COVID-19). Two days later, the FDA issued another four warning letters for similar reasons. Two of the five warning letters issued on April 6 were issued to companies in connection with their CBD products, and one of the warning letters issued on April 8 was issued to a CBD company as well ...
Key Points A new FDA rule clarifies when food manufacturers may label fermented or hydrolyzed foods as gluten-free. Manufacturers making gluten-free claims must maintain records showing that the foods or food ingredients used in the foods are gluten-free prior to fermentation or hydrolysis. A product marked as gluten-free may be deemed misbranded under the Food, Drug, and Cosmetics Act if its manufacturer does not maintain supporting documentation to the satisfaction of the FDA ...
The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020. This nonbinding guidance is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services. The guidance advises vaccine development and licensure following the standard trial progression but on an accelerated timeline ...
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 ...
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 ...
The U.S. Food and Drug Administration (FDA) recently issued a burst of COVID-19-related guidance documents to facilitate expanded availability of medical products during the current public health emergency created by COVID-19. FDA-regulated products under these temporary policies include: PPE, diagnostic tests, hand sanitizers, disinfectant devices, remote monitoring devices, ventilators, and electronic thermometers for clinical use ...
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 ...
On June 3, 2024, a divided three-judge panel of the United States Court of Appeals for the Eleventh Circuit ruled that an Atlanta hedge fund likely violated 42 U.S.C. § 1981—the federal prohibition on racial discrimination in public and private contracting—by operating a grant contest that awarded $20,000 grants to select small business owners, all of whom, by the contest’s express rules, had to be Black women ...
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 D.C. Circuit Court of Appeals has rejected the petitions of numerous states and industry groups that challenged several rules EPA issued to control greenhouse gas emissions from stationary and mobile sources.1 Following the United States Supreme Court’s decision in Massachusetts v ...
On Dec. 3, 2019, the Board of Governors of the Federal Reserve System, the Federal Deposit Insurance Corporation (FDIC), the Financial Crimes Enforcement Network (FinCEN) and the Office of the Comptroller of Currency (OCC) in conjunction with the Conference of State Bank Supervisors (CSBS) issued a joint statement entitled “Providing Financial Services to Customers Engaged in Hemp-Related Businesses ...
On October 29, the OCC, the Federal Reserve, the FDIC, the NCUA and the CFPB (collectively, the “agencies”) issued a Notice of Proposed Rulemaking (“NPR”) to clarify and make into a rule the prior Interagency Statement Clarifying the Role of Supervisory Guidance issued on September 11, 2018 (“2018 Statement”). Comments on the NPR are due within 60 days of the date the NPR is published in the Federal Register ...
On April 7, 2022, Finance Minister Chrystia Freeland tabled the federal government?s new budget for 2022. This budget includes several tax measures relevant to the mining industry in Canada. The Canadian federal government intends to provide $3.8 billion over eight years to implement Canada?s first critical minerals strategy ...
The Fourth Circuit Court of Appeals (covering Virginia, West Virginia, North Carolina, South Carolina, and Maryland) held that gender dysphoria, a condition experienced by some transgender individuals, is a protected disability under the Americans with Disabilities Act. See Williams v. Kincaid, No. 21-2030 (4th Cir. Aug. 16, 2022) ...
The Federal Civil Liability Law was published in the Federal Official Gazette on December 31, 2004 and entered into full force and effect in January 1, 2005. This law has as its objective that of determining the bases and proceedings for recognizing the right to claim indemnification by those suffering loss or damage as a consequence of improper actions of the executive, legislative, and judicial branches of the federal government and its agencies ...
Starting January 30, 2022, new federal contracts that are not procurement contracts must include a clause requiring federal contractors to pay at least $15 per hour to workers performing work on or in connection with the federal contract. That minimum wage rate will increase annually based on changes to the Consumer Price Index. The federal government predicts that this requirement may impact over half a million firms. Federal contractors with procurement contracts (i.e ...
Many federal contractors are required to file Type 2 Consolidated Employer Information Reports, Standard Form 100 (EEO-1 Reports). Generally, employers that are subject to Title VII of the Civil Rights Act of 1964, as amended, and has 100 or more employees must file an EEO-1 Report with the Equal Employment Opportunity Commission (EEOC) ...
On 27 May 2020 the Federal Council adopted the Ordinance on Protecting against Cyber Risks (OPCy, available in French and German), which is set to enter into force on 1 July 2020. This move is the next step in a series of measures taken by the Federal Council to adopt a new organisational structure and implement a national strategy to protect Switzerland against cyber risks (NCS, available in German, French, Italian and English) ...
In Yves Choueifaty v. Attorney General of Canada 1 , the Federal Court of Canada has issued a significant decision concerning the assessment of patent-eligible subject matter, including the approach to be used for such assessment during the examination of Canadian patent applications ...
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 ...
In response to a lawsuit filed by the State of New York, a judge in the Southern District of New York considered and invalidated parts of the Department of Labor's (“DOL”) Final Rule implementing the Families First Coronavirus Relief Act (“FFCRA”). The ruling, while currently only applying to employers in the Southern District of New York (i.e., New York City), could be instructive on how other courts consider the same provisions ...
The Centers for Medicare and Medicaid Services' (CMS) vaccine mandate (Mandate)[1] has been preliminarily enjoined[2] on a nationwide basis due to a Nov. 30, 2021, decision by Judge Terry A. Doughty of the Western District Court of Louisiana, Monroe Division. Among other conclusions, Judge Doughty stated that mandating vaccination of health care workers should be done by Congress, not a government agency, although he also questioned whether even Congress had such authority ...
