💊Request for Comments on National Security Investigation of Pharmaceuticals
The Secretary of Commerce initiated an investigation to determine the effects on the national security of imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items. This investigation has been initiated under section 232 of the Trade Expansion Act of 1962, as amended. Interested parties are invited to submit written comments, data, analyses, or other information pertinent to the investigation to the Department of Commerce's (Department) Bureau of Industry and Security (BIS), Office of Strategic Industries and Economic Security. This notice identifies issues on which the Department is especially interested in obtaining the public's views.
Learn More💊Merck's FTZ 49 Notification for Pharmaceutical Production Activity
Merck, Sharp & Dohme LLC has submitted a notification to the Foreign-Trade Zones Board for proposed production activities at its facility in Rahway, New Jersey. The notification includes plans for various pharmaceutical products intended for research and development, alongside a list of foreign-status materials and components that will benefit from FTZ procedures. Public commentary is invited ahead of the final approval.
Learn More🚫FDA Withdraws Approval for 18 New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Learn More💊FDA Confirms FLUMADINE Not Withdrawn for Safety or Effectiveness
The Food and Drug Administration (FDA, the Agency, or we) has determined that FLUMADINE (rimantadine hydrochloride) tablet, 100 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness.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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Learn More💊FDA Confirms NASCOBAL Status, Impacting Generic Approvals
The Food and Drug Administration (FDA, Agency, or we) has determined that NASCOBAL (cyanocobalamin) nasal spray, 0.5 milligram (mg)/spray, was 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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Learn More💊FDA Decision on ETHYOL
The Food and Drug Administration (FDA, the Agency, or we) has determined that ETHYOL (amifostine) for injection, 500 milligrams (mg)/ vial, was 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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Learn More💉FDA Updates on Susceptibility Test Interpretive Criteria Announced
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
Learn More💊USITC Notice of Complaint on Certain Drug Products and Public Interest
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Drug Products Containing C-Type Natriuretic Peptide Variants, and Components Thereof, DN 3819; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.
Learn More💊AstraZeneca's FTZ Production Notification for Pharmaceuticals
AstraZeneca Pharmaceuticals LP has submitted a notification for proposed production activities related to zibotentan/dapagliflozin tablets in Foreign-Trade Zone (FTZ) 177 in Indiana. The notification aligns with FTZ regulations, detailing duty-free benefits for specified foreign-status materials and products while inviting public comment on the proposal.
Learn More⚖️DEA Revokes Prescript Pharmaceuticals' Registration for Violations
The Drug Enforcement Administration issued an Order of Revocation against Prescript Pharmaceuticals after it violated federal regulations pertaining to the procurement of controlled substances. The order highlights the importance of compliance with the Controlled Substances Act, especially concerning the requirement for obtaining procurement quotas for manufacturing activities, and could set a precedent affecting other registrants.
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