Category: Regulatory/FDA

Regulatory/FDA

Regulatory/FDA

FCC Proposes Codifying New TCPA Consent Rules in Notice of Proposed Rulemaking

FCC Proposes Codifying New TCPA Consent Rules in Notice of Proposed Rulemaking

The Federal Communications Commission (FCC) has issued a Notice of Proposed Rulemaking intending to strengthen consumers’ ability to revoke consent to receive both robocalls and robotexts, in addition to strengthening callers’/texters’ obligations to honor such requests in a timely manner. The Telephone Consumer Protection Act (TCPA) restricts callers from making robocalls and robotexts unless they have received […]

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Regulatory/FDA

Federal Government Agencies Issue Rule to Ban TikTok on Contractor Devices

Federal Government Agencies Issue Rule to Ban TikTok on Contractor Devices

The Federal Acquisition Regulation Council (“FAR Council”) published an interim rule on June 2 prohibiting federal contractors from using TikTok on government devices, The rule specifies that the ban on TikTok and other ByteDance-developed services “applies to devices regardless of whether the device is owned by the government, the contractor or the contractor’s employees,” including “employee-owned devices […]

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Regulatory/FDA

NLRB General Counsel Issues Memo Indicating Non-Competes Are Unlawful in Almost All Cases

NLRB General Counsel Issues Memo Indicating Non-Competes Are Unlawful in Almost All Cases

On May 30, National Labor Relations Board (NLRB) General Counsel Jennifer Abruzzo sent a memo to all Regional Directors, Officers-in-Charge, and Resident Officers, deeming that the act of extending, maintaining, and enforcing of non-compete provisions in employment contracts and severance agreements seemingly violates the National Labor Relations Act (NLRA) except in limited circumstances. NLRB General Counsel Abruzzo’s […]

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Regulatory/FDA

FTC Proposes Changes to Health Breach Notification Rule to Strengthen Health App Applicability

FTC Proposes Changes to Health Breach Notification Rule to Strengthen Health App Applicability

On May 18, 2023, the Federal Trade Commission (FTC) announced its intention to issue proposed amendments to the federal Health Breach Notification Rule (HBNR), with the goal of trying to improve patient privacy protections for Americans utilizing digital health apps. Published on May 22, 2023 in the Federal Register, the public has a 60-day window to comment on the […]

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Regulatory/FDA

FAQ: HIPAA Proposed Rule to Support Reproductive Health Care Privacy

FAQ: HIPAA Proposed Rule to Support Reproductive Health Care Privacy

The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released the HIPAA Privacy Rule to Support Reproductive Health Care Privacy proposed rule on April 12, 2023 aimed at providing additional requirements around the sharing of protected health information (PHI) relating to patient initiated and provider administered reproductive health care. OCR has […]

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Regulatory/FDA

4A’s Submits Comments to FTC on Environmental Claims in Marketing (i.e. “Green Guides”)

4A’s Submits Comments to FTC on Environmental Claims in Marketing (i.e. “Green Guides”)

On April 24, 2023, the 4A’s submitted written comments to the Federal Trade Commission (FTC) regarding advertising agency recommendations for potential updates to the FTC Green Guides. The FTC published a Request for Comment in December 2022 to seek public input into potential updates and changes to the Green Guides for the Use of Environmental Claims. The FTC Green […]

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Regulatory/FDA

FDA Accelerated Approval Program Is Under Spotlight Again with Makena

FDA Accelerated Approval Program Is Under Spotlight Again with Makena

Oct. 28, 2022 – The Food and Drug Administration’s (FDA’s) accelerated approval process is being scrutinized anew following a recent FDA advisory committee recommendation to remove from the market Covis Pharma’s Makena, a drug that received an accelerated approval in 2011 to help prevent pre-term births. According to a September report from the Office of […]

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Regulatory/FDA

OPDP: Risk, Efficacy Claims for Cholesterol Drug in Doctor Promotion Are False/Misleading

OPDP: Risk, Efficacy Claims for Cholesterol Drug in Doctor Promotion Are False/Misleading

June 27, 2022 – False or misleading claims and representations in a professional promotion about the efficacy and risks of a prescription drug for high cholesterol are cited in a June 2 Untitled Letter from the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) to Althera Pharmaceuticals LLC. OPDP reviewed a “Doctor […]

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Regulatory/FDA

HHS Formally Withdraws SUNSET Final Rule

HHS Formally Withdraws SUNSET Final Rule

June 20, 2022 – The Department of Health and Human Services (HHS) has formally withdrawn a Trump administration rule that threatened to cause many HHS regulations to expire. HHS announced its decision in a recent 133-page withdrawal notice in the Federal Register, stating that the “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) final rule […]

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Regulatory/FDA

OPDP Reorg, Outreach Efforts Designed to Improve Relationship with Industry

OPDP Reorg, Outreach Efforts Designed to Improve Relationship with Industry

June 13, 2022 – From a staff reorganization to a monthly newsletter to increased collaborations with stakeholders, in 2022 the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) – under the direction of Dr. Catherine “Katie” Gray – has made a series of organizational and communications moves to make OPDP both more transparent […]

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