Federal Register

Lykos Therapeutics Announces FDA Advisory Committee Meeting to Review Investigational MDMA-Assisted Therapy for PTSD

Retrieved on: 
월요일, 5월 6, 2024
Federal Register, FDA, Capsule, Person, Priority review, NDA, Post-traumatic stress disorder, Food, Safety, PTSD, MAPS, Psychotherapy, PDAC, MDMA, PDUFA, Volume, OPH, Diagnosis, PBC, Therapy, SAN, Pharmaceutical industry

This will be the first FDA advisory committee meeting to review a potential new PTSD treatment in 25 years.1 As with all advisory committee meetings, there will be an open public hearing (OPH) session, during which interested persons may present relevant information or views orally or in writing.

Key Points: 
  • This will be the first FDA advisory committee meeting to review a potential new PTSD treatment in 25 years.1 As with all advisory committee meetings, there will be an open public hearing (OPH) session, during which interested persons may present relevant information or views orally or in writing.
  • "This will be the first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by the Psychopharmacologic Drugs Advisory Committee, a significant milestone in the field of psychedelic medicine, resulting from decades of clinical research and advocacy," said Amy Emerson, Chief Executive Officer of Lykos Therapeutics.
  • The FDA granted the application Priority Review and has assigned a Prescription Drug User Fee Act ("PDUFA") target action date of August 11, 2024.
  • At Lykos Therapeutics, a public benefit corporation (PBC) founded by MAPS, our mission is to transform mental healthcare.

USDA Finalizes Policy to Protect Consumers from Salmonella in Raw Breaded Stuffed Chicken Products

Retrieved on: 
금요일, 4월 26, 2024
Poultry, Federal Register, Sale, Public, Food safety, Risk, Policy, Food, CDC, Disease, Animal, Salmonellosis, USDA, Guideline, Farmer, Agriculture, CFU, Science, STEC, Escherichia coli, Register, Infection, FSIS, Poultry farming

“This final determination marks the first time that Salmonella is being declared an adulterant in a class of raw poultry products.

Key Points: 
  • “This final determination marks the first time that Salmonella is being declared an adulterant in a class of raw poultry products.
  • If the chicken component in these products does not meet this standard, the product lot represented by the sampled component would not be permitted to be used to produce the final raw breaded stuffed chicken products.
  • In determining that Salmonella is an adulterant in raw breaded stuffed chicken products, FSIS considered the best available science and data using similar criteria as in its 1994, 1999, and 2011 E. coli policymaking.
  • Raw breaded stuffed chicken products are pre-browned and may appear cooked, but the chicken is raw.

Joint Statement Applauding Final Rule for Web Accessibility Under Title II of the ADA

Retrieved on: 
수요일, 4월 10, 2024
Education, Federal Register, Organization, American Council, Disability discrimination act, Disability, NFB, Justice, Digital, Research, ACB, AFB, App Store (iOS/iPadOS), Register, Health

The rule is awaiting official publication in the Federal Register.

Key Points: 
  • The rule is awaiting official publication in the Federal Register.
  • This rule is the product of more than 14 years of advocacy and rulemaking to address these entities’ obligations under the Americans with Disabilities Act.
  • State and local governments use websites and mobile applications to deliver timely information and services across the full spectrum of their operations.
  • Going forward, we will continue advocating for full implementation of this rule and others that expand access to the digital tools that we all rely on.

How “location, location, location” can lead to “enforcement, enforcement, enforcement”

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금요일, 4월 12, 2024
Federal Register, Comment, Walking, Checkpoint, Register, Location, Boil, Policy, Blog, Record, Nature, Commission, Complaint, Advertising, Fraud, Pharmacy, SDK, Privacy, Collection, Marketing, IOS, Parent, Work, Android, Federal Trade Commission, FTC, Satellite navigation device

How “location, location, location” can lead to “enforcement, enforcement, enforcement”

Key Points: 

How “location, location, location” can lead to “enforcement, enforcement, enforcement”

SEC Adopts Reforms Relating to Investment Advisers Operating Exclusively Through the Internet

Retrieved on: 
수요일, 3월 27, 2024
Form, Register, Commission, Internet, Federal Register, Security (finance), Financial adviser

Washington, D.C.--(Newsfile Corp. - March 27, 2024) - The Securities and Exchange Commission today adopted amendments to the rule permitting certain internet investment advisers to register with the Commission (the “internet adviser exemption”).

Key Points: 
  • Washington, D.C.--(Newsfile Corp. - March 27, 2024) - The Securities and Exchange Commission today adopted amendments to the rule permitting certain internet investment advisers to register with the Commission (the “internet adviser exemption”).
  • The amendments will require an investment adviser relying on the internet adviser exemption to have at all times an operational interactive website through which the adviser provides digital investment advisory services on an ongoing basis to more than one client.
  • “These amendments modernize a 22-year-old rule to better protect investors in a digital age,” said SEC Chair Gary Gensler.
  • Most investment advisers will have filed their annual updating amendments to Form ADV by this date i.e., 90 days after the Dec. 31, 2024, fiscal year end).

Wolters Kluwer compliance professionals to discuss new Community Reinvestment Act regulations

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금요일, 3월 15, 2024
Legal, Technology, Finance, Consulting, Fintech, Accounting, Professional Services, Small Business, Software, Community, Wolters Kluwer, Register, FCC, CRA, Federal Register, CT Corporation, Risk management, Interview, Telescope

Compliance professionals from Wolters Kluwer Compliance Solutions will host a webinar this month to discuss key definitional changes under the final rule amending the Community Reinvestment Act (CRA) regulations.

Key Points: 
  • Compliance professionals from Wolters Kluwer Compliance Solutions will host a webinar this month to discuss key definitional changes under the final rule amending the Community Reinvestment Act (CRA) regulations.
  • Regulatory compliance professionals Jason Keller and Kris Stewart of the Wolters Kluwer Financial & Corporate Compliance division will provide an overview of these definitional changes to help guide CRA practitioners through their organizations’ updated rule implementation processes.
  • Reporters wishing to arrange an interview on navigating CRA compliance obligations with Wolters Kluwer experts, such as Keller and Stewart, are invited to contact David Feider , Associate Director, External Communications, Wolters Kluwer FCC.
  • Wolters Kluwer Compliance Solutions is a market leader and trusted provider of risk management and regulatory compliance solutions and services to U.S. banks, credit unions, insurers and securities firms.

XCL Resources Seeks FTC’s Prior Approval for Altamont Energy Acquisition

Retrieved on: 
화요일, 4월 2, 2024
Carbon, Natural gas, Federal Register, Regulations.gov, Register, Social media, Blog, News, Acquisition, EnCap, XCL, Federal Trade Commission, FTC, Oil

The Federal Trade Commission is requesting public comment on an application from XCL Resources Holdings, LLC, a subsidiary of private equity firm EnCap Investment L.P., seeking prior approval from the agency to complete its proposed acquisition of Altamont Energy, LLC, an oil and gas operator in the Uinta Basin region of Utah.

Key Points: 
  • The Federal Trade Commission is requesting public comment on an application from XCL Resources Holdings, LLC, a subsidiary of private equity firm EnCap Investment L.P., seeking prior approval from the agency to complete its proposed acquisition of Altamont Energy, LLC, an oil and gas operator in the Uinta Basin region of Utah.
  • XCL’s petition to the FTC stems from the Commission’s 2022 final order regarding EnCap Energy Capital Fund XI, L.P.’s $1.445 billion acquisition of EP Energy Corp.
  • XCL is a private equity-owned oil and gas company based in Houston, Texas.
  • For the latest news and resources, follow the FTC on social media, subscribe to press releases and read our blog.

FTC Implements New Protections for Businesses Against Telemarketing Fraud and Affirms Protections Against AI-enabled Scam Calls

Retrieved on: 
화요일, 4월 2, 2024
Pernicious, Consumer protection, TSR, Federal Register, Federal Trade Commission, Register, Social media, Blog, News, Small business, Record, Do not call list, Commission, DNC, Technical support, Deception, Advertising, FTC

The Federal Trade Commission today announced a final rule extending telemarketing fraud protections to businesses and updating the rule’s recordkeeping requirements in light of developments in technology and the marketplace. The Commission also announced a proposed rule that would provide the agency with significant new tools to combat tech support scams. Both actions are part of the Commission’s current review of the Telemarketing Sales Rule (TSR), which includes the Do Not Call Registry (DNC) rules and provisions banning nearly all telemarketing robocalls to consumers.

Key Points: 


The Federal Trade Commission today announced a final rule extending telemarketing fraud protections to businesses and updating the rule’s recordkeeping requirements in light of developments in technology and the marketplace. The Commission also announced a proposed rule that would provide the agency with significant new tools to combat tech support scams.

  • Both actions are part of the Commission’s current review of the Telemarketing Sales Rule (TSR), which includes the Do Not Call Registry (DNC) rules and provisions banning nearly all telemarketing robocalls to consumers.
  • Importantly, the FTC also affirms the TSR’s prohibitions on robocalls using voice cloning technology.

The Current Regulatory Review


Both the final rulemaking and notice of proposed rulemaking announced today stem from the Commission’s regulatory review of the TSR and address public comments received as part of that review. In April 2022, the FTC proposed extending telemarketing protections to businesses and strengthening safeguards against other pernicious telemarking tactics plaguing consumers. The final rule announced today implements updates that:

The Tech Support Notice of Proposed Rulemaking

  • The notice of proposed rulemaking announced today proposes amending the TSR to extend its coverage to inbound telemarketing calls involving technical support services.
  • The proposed amendment is needed due to the widespread deception and consumer injury caused by tech support scams, including those in which consumers call supposed tech support operations in response to advertising.
  • The Commission also is seeking comments on a proposed definition of tech support scams.

FTC to Hold Virtual Informal Hearing on April 24, 2024 As Part of its Review of the Proposed Rule Prohibiting Junk Fees

Retrieved on: 
화요일, 4월 2, 2024
Register, Commission, Administrative law, Organization, Federal Register, Social media, Blog, News, Hearing, Running, Federal Trade Commission, FTC

The Federal Trade Commission will hold a virtual informal hearing on April 24, 2024, on its proposed Rule on Unfair or Deceptive Fees, commonly known as junk fees.

Key Points: 
  • The Federal Trade Commission will hold a virtual informal hearing on April 24, 2024, on its proposed Rule on Unfair or Deceptive Fees, commonly known as junk fees.
  • On October 11, 2023, the Federal Trade Commission announced a proposed rule to prohibit junk fees.
  • In response to the proposed rulemaking, 17 commenters requested to present their positions at an informal hearing.
  • The Federal Register notice states that these entities will be entitled to make oral presentations at the informal hearing on April 24, 2024.