📄FDA Announces M11 Technical Specification for Clinical Trials
The Food and Drug Administration (FDA or Agency) is announcing the availability of the revised draft technical specification entitled "M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol (CeSHarP)" and a supplemental document entitled "M11 Template." The revised draft technical specification and template were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The revised draft technical specification recommends the use of an open, nonproprietary standard to enable electronic exchange of clinical protocol information. The template identifies headers, common text, and a set of data fields and terminologies that will be the basis for efficiencies in data exchange. These ICH documents create an international standard for the content and exchange of clinical trial protocol information facilitating review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This revised draft technical specification and updated template revise and replace the draft versions of the same titles issued in December 2022.
Learn More💊FDA Draft Guidance on OTC Monograph Minor Changes Available
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs." The purpose of this guidance is to provide recommendations for how requestors can comply with the requirements described in the Proposed Administrative Order (OTC000038) titled Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs (hereinafter referred to as C001).
Learn More🚫U.S. Trade Commission Issues Exclusion Order for Pharmaceutical Violations
Notice is hereby given that the U.S. International Trade Commission has found a violation of section 337 of the Tariff Act of 1930, as amended, in the above-captioned investigation by respondents Ascletis Pharma Inc. of Hangzhou, Zhejiang Province, China; Ascletis Pharmaceuticals Co. Ltd. of Shaoxing, Zhejiang Province, China; Ascletis Bioscience Co., Ltd. of Hangzhou, Zhejiang Province, China; and Gannex Pharma Co., Ltd. of Shanghai, China (collectively, "Corporate Respondents"), based on their misappropriation of certain asserted trade secrets. The Commission has determined to issue a seven-year limited exclusion order ("LEO") prohibiting the unlicensed entry into the United States of certain selective thyroid hormone receptor-beta agonists, processes for manufacturing or relating to same, and products containing same, imported by or on behalf of the Corporate Respondents, and a cease and desist order ("CDO") against each of the Corporate Respondents. The investigation is terminated.
Learn More💊FDA Report on Drug Firms' Postmarketing Requirements and Commitments
The Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency's annual report entitled "Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments." Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. The report on the status of the studies and clinical trials that applicants are required to, or have agreed to, conduct is on FDA's website entitled "Postmarketing Requirements and Commitments: Reports" (https://www.fda.gov/drugs/postmarketing- requirements-and-commitments-introduction/postmarketing-requirements- and-commitments-reports).
Learn More💊USTR Seeks Comments on Foreign Nations Impacting Pharma Innovation
Pursuant to the Executive Order titled Delivering Most- Favored-Nation Prescription Drug Pricing to American Patients, USTR invites comments from interested parties regarding any act, policy, or practice that may be unreasonable or discriminatory and that has the effect of forcing American patients to pay for a disproportionate amount of global pharmaceutical research and development, including by suppressing the price of pharmaceutical products below fair market value in foreign countries.
Learn More📄FDA Announces Draft Guidance for Roflumilast Bioequivalence
The Food and Drug Administration (FDA or Agency) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Roflumilast." The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for roflumilast topical cream.
Learn More📦DEA Notice
Research Triangle Institute has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Learn More💊FDA Notice on Drug Products Not Withdrawn for Safety Reasons
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Learn More💊ITC Investigation on Drug Products and Patent Violations
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 2, 2025, under section 337 of the Tariff Act of 1930, as amended, on behalf of BioMarin Pharmaceutical Inc. of Novato, California. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain drug products containing C-type natriuretic peptide variants and components thereof by reason of the infringement of certain claims of U.S. Reissue Patent No. RE48,267 (the "RE'267 patent"). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
Learn More⚖️Revocation of DEA Registration for Mohan Kaza Due to Violations
The Drug Enforcement Administration issued a decision revoking Dr. Mohan Kaza's DEA registration, citing multiple violations of the Controlled Substances Act related to improper prescribing practices. The order reveals serious concerns regarding public safety and compliance with legal standards, ultimately leading to the termination of his ability to prescribe controlled substances.
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