NIH seeks public input on its proposed NIH Policy on Sharing Summary Level Study Results with Clinical Research Participants, including ways to promote and enable the research community to share summary level study results with clinical research participants.

Original title: “Draft NIH Policy on Sharing Summary Level Study Results With Clinical Research Participants”

The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D<INF>2</INF> inactive bakers yeast as a source of vitamin D<INF>2</INF> in specific food categories. We are taking this action in response to a food additive petition filed by Lallemand Inc. (Lallemand or petitioner).

Original title: “Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast”

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jeffrey Thies for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Thies was convicted of two felony counts under Federal law for trafficking in counterfeit goods and aiding and abetting. The factual basis supporting Mr. Thies's conviction, as described below, is conduct r

Original title: “Jeffrey Thies: Final Debarment Order”

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Naveed Aslam from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Aslam was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Dr. Aslam was given notice of the proposed debarme

Original title: “Naveed Aslam: Final Debarment Order”

The Food and Drug Administration (FDA or we) is announcing that we have filed a color additive petition, submitted by Doehler GmbH, c/o Hogan Lovells Cadwalader, proposing that we amend our color additive regulations to provide for the safe use of calcium sulfate in various foods at levels consistent with good manufacturing practice.

Original title: “Filing of Color Additive Petition From Doehler GmbH; Request To Amend the Color Additive Regulations To Provide for the Safe Use of Calcium Sulfate in Various Foods at Levels Consistent With Good Manufacturing Practice”

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Robotically-Assisted Surgical Devices--Premarket Submissions." This draft guidance provides draft recommendations for premarket submissions for robotically- assisted surgical devices (RASDs). This draft guidance is not final nor is it for implementation at this time.

Original title: “Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability”

Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on key decisions and work to speed early drug research.

Original title: “FDA nominee Overton parries vaccine questions at Senate hearing”

FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly’s tirzepatide and Novo’s semaglutide “regularly or in inordinate amounts” at a site with “insanitary conditions.”

Original title: “FDA slams GLP-1 compounder over risk of contaminating drugs ‘with filth’”

In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as her views on vaccines and abortion drugs.

Original title: “US senators grill FDA nominee Overton on ability to ‘stand up’ to Trump”

The Department of Health and Human Services (HHS) is opening a public docket to solicit input, supporting data, and comments to assist HHS as it considers how best to regulate deceased donor islet cells and/or deceased donor islet cell products for the treatment of Type 1 diabetes (T1D). The purpose of this information is to allow HHS agencies to better understand how best to regulate these therapies, including whether and how regulation could differ between isolated and otherwise unmodified dec

Original title: “Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information”

This request for information (RFI) solicits input from interested parties for purposes of establishing standards for reasonable and relevant pharmacy contract terms and conditions under the Medicare prescription drug benefit. Section 6223(a) of the Consolidated Appropriations Act, 2026 (CAA, 2026) amends section 1860D- 4(b)(1)(A) of the Social Security Act (the Act) to require Part D plan sponsors to permit any pharmacy that meets standard contract terms and conditions under the plan to particip

Original title: “Request for Information; Medicare Part D Reasonable and Relevant Pharmacy Contracting Standards”

Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (consideration: CR S5020; text: CR S5007-5008)

Original title: “SRES 902: A resolution supporting the designation of the week of September 20 through September 26, 2026, as "Telehealth Awareness Week".”

Health centers with a current period of performance of January 1, 2023, through December 31, 2026; February 1, 2023, through January 31, 2027; or March 1, 2023, through February 28, 2027, are required to apply to continue serving their service area through a fiscal year 2027 Service Area Competition in response to a Notice of Funding Opportunity once issued. To avoid a gap in services in service areas served by these health centers, health centers with a current period of performance of January

Original title: “Health Center Program Performance Period Extensions”

Referred to the House Committee on Foreign Affairs.

Original title: “HR 10600: To amend the Foreign Assistance Act of 1961 to authorize the use of Federal foreign assistance funds for comprehensive reproductive health care services, and for other purposes.”

Referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S5006)

Original title: “SRES 899: A resolution recognizing suicide as a serious public health problem and expressing support for the designation of September as "National Suicide Prevention Month".”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 5564: STOP Neglected Diseases of Poverty Act”