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June 11, 2020

CPG Sec.140.500 Metric Declarations of Quantity of Contents on Product Labels

The Metric Conversion Act of 1975 (80 stat 1007) was enacted to voluntarily increase the use of the metric system of weights and measures in the […]
June 11, 2020

CPG Sec. 140.100 Seizure of Books that Constitute Misleading Labeling

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: For many years, the agency has recommended the seizure not only of violative articles but also […]
June 11, 2020

CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: The agency has received many questions concerning the use of microfiche and/or microfilm systems in lieu […]
June 11, 2020

CPG Sec 110.900 Imported Products – Lack of English Labeling

Issued by: Guidance Issuing Office Office of Regulatory Affairs Center for Food Safety and Applied Nutrition BACKGROUND: Violative imported products should preferably be handled at the […]
June 11, 2020

CPG Section 110.800 Post Detention Sampling Guidance for Industry

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 – Specific Electronic Submissions Intended For FDA’s Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed […]
June 11, 2020

CPG Sec. 110.700 Seizures by the U.S. Customs Service of Prohibited Articles of Foreign Origin Not Intended for Entry into the United States

Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: 19 CFR 18.21(b) states: “Narcotics and other articles prohibited admission into commerce of the United States […]
June 11, 2020

FDA approves nivolumab for esophageal squamous cell carcinoma

On June 10, 2020, the Food and Drug Administration approved nivolumab (OPDIVO, Bristol-Myers Squibb Co.) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell […]
June 11, 2020

Complex Innovative Trial Designs Pilot Program

On this page As displayed in the Federal Register notice on August 29, 2018, FDA is conducting a Complex Innovative Trial Design (CID) Pilot Meeting Program […]
June 10, 2020

Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to A Labeling Error

Summary Company Announcement Date: September 12, 2019 FDA Publish Date: September 12, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Label mix-up Company Name: […]
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