In 1983, the United States Congress passed the Orphan Drug Act, defining a rare (or “orphan”) disease as a condition affecting fewer than 200,0 | Cancer

Original title: “Orphan Diseases and Their Impact on Anticancer Drugs | Cancer”

The National Institute on Deafness and Other Communication Disorders (NIDCD) seeks comments and suggestions from the public in response to one question: Are there new and emerging areas of science with the potential to impact the health and wellbeing of people with disorders of hearing, balance, taste, smell, voice, speech and language that are not reflected in the themes and goals of the NIDCD Strategic Plan? Responses to this RFI will be considered as NIDCD updates its current strategic plan.

Original title: “Request for Information (RFI): Request for Information on New and Emerging Areas of Science Relevant to the NIDCD Mission, To Inform an Update of the NIDCD Strategic Plan for 2028-2032”

The current classifications of vaccine recommendations could imply that not all shots require the consent of patients or their parents, according to Health Secretary Robert F. Kennedy Jr.

Original title: “Kennedy questions vaccination guidelines following Trump’s order to break up MMR”

Following a tumultuous stretch under ex-Commissioner Marty Makary, current FDA leadership is working to restore reliability, integrity and transparency to the agency—but experts say that doesn’t necessarily mean an easier regulatory road for drugmakers.

Original title: “Capricor, Replimune reviews signal FDA’s return to reliability but every application will stand alone”

Several MMWR articles provide information about Powassan virus disease cases in the United States.

Original title: “Resources”

Learn how the PHIFP trains informatics professionals for public health work.

Original title: “About The Public Health Informatics Fellowship Program (PHIFP)”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Evaluation of Therapeutic Equivalence." This guidance explains FDA's thinking on therapeutic equivalence evaluations and therapeutic equivalence codes (TE codes). FDA's therapeutic equivalence evaluations are listed for multisource prescription drug products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the active section of the "Approved Drug Products

Original title: “Evaluation of Therapeutic Equivalence; Guidance for Industry; Availability”

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry titled "Bioequivalence Recommendations for Specific Products" that explai

Original title: “Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability”

The Food and Drug Administration (FDA or the Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 066" (Recognition List Number: 066), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical d

Original title: “Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066”

The Department of Health and Human Services (HHS or the Department), in support of the Task Force on Safer Childhood Vaccines and in furtherance of the Executive Order of August 10, 2026, "Delivering Gold Standard Childhood Vaccine Recommendations for Americans," seeks public comment on whether the categories currently used in Federal vaccine recommendations are adequate. Those categories are routine (universal) recommendations, risk-based recommendations, and recommendations based on shared cli

Original title: “Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making”

The Food and Drug Administration (FDA) is announcing the renewal of the Oncologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Oncologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the September 1, 2028, expiration date.

Original title: “Advisory Committee; Oncologic Drugs Advisory Committee; Renewal”

Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Workforce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 10133: To amend title XXVII of the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to ensure cost sharing for a drug does not exceed the nationwide average of consumer purchase prices for such drug.”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 10127: To prohibit the use of Federal funds to conduct, support, or fund research that studies the effects of gender-related medical treatment, and for other purposes.”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled "Potency Assessment of Active Immunotherapy Products." The draft guidance document provides recommendations for developing assays to assess potency as a part of a potency assurance strategy for active immunotherapy products (ACTIMPs). When finalized, this guidance will describe the FDA's current thinking regarding design, validation, and evaluation of potency tests for ACTIMPs. This guidanc

Original title: “Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability”

The Food and Drug Administration (FDA) is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Endocrinologic and Metabolic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the August 27, 2028, expiration date.

Original title: “Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal”

The Food and Drug Administration (FDA) is announcing the renewal of the Cardiovascular and Renal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Cardiovascular and Renal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the August 27, 2028, expiration date.

Original title: “Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal”