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FDA Announces New Guidance Documents on Drug Products
August 7, 2017 |FDA

The Food and Drug Administration announced the availability of new guidance documents on drug products. The draft guidances provide "product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs)," FDA said. The new guidance documents cover Acarbose; Acetaminophen, Aspirin, Caffeine; Acetaminophen, Butalbital, Caffeine, Codeine phosphate; Acitretin; Amoxicillin (multiple reference listed drugs); Amoxicillin, Clavulanate Potassium; Aspirin, Butalbital, Caffeine (multiple reference listed drugs); Aspirin, Butalbital, Caffeine, Codeine Phosphate; Atenolol; Atenolol and Chlorthalidone; Cetirizine HCl; Chlorthalidone; Citalopram HBr; Citalopram hydrobromide; Clarithromycin; Clindamycin HCl; Clomiphene Citrate; Clonazepam; Clozapine; Cyclobenzaprine HCL; Cycloserine; Dapsone; Desipramine HCl; Desmopressin Acetate; Diflunisal; Diphenhydramine HCl; Dipyridamole; Disulfiram; Donepezil HCl; Doxazosin mesylate; Doxepin HCl; Doxercalciferol; Eprosartan Mesylate; Ethambutol HCl; Hydrochlorothiazide, Losartan Potassium; Hydrochlorothiazide, Triamterene; Hydrochlorothiazide, Valsartan; Hydrocodone bitartrate, Ibuprofen; Hydrocortisone; Hydromorphone HCl; Selegiline hydrochloride; Sotalol HCl; Tenofovir Disoproxil Fumarate; Tiagabine HCl; Valproic acid; and Verapamil HCl.

FDA Posts Draft Guidance on Child-Resistant Packaging Statements in Drug Labeling
August 7, 2017 |FDA

The Food and Drug Administration on Aug. 2 posted a new draft guidance document on child-resistant packaging statements in drug labeling, it said in a notice. The document is “intended to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging (CRP) statements in prescription and over-the-counter human drug product labeling,” FDA said. Topics covered include what information that should be included to support statements in labeling for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements to these applications, FDA said. Comments are due Oct. 2.

FDA Releases Guidance on FSMA Compliance for Low-Acid Canned Foods, Juice and Seafood
August 7, 2017 |FDA

The Food and Drug Administration on Aug. 7 announced the publication of three new guidance documents to help food producers and importers of low-acid canned foods, juice and seafood comply with new regulations under the Food Safety Modernization Act. The documents explain how FSMA requirements apply to producers and importers subject to FDA’s regulations on low-acid canned foods and hazard analysis and critical control point (HACCP) regulations for seafood and juice are expected to comply with FSMA’s requirements, including those of the Foreign Supply Verification Program regulations. “FSMA recognizes that FDA has previously-established regulations that are specific to seafood, juice, and LACF and so some exemptions have been made in the FSMA rules for these products,” FDA said. “However, there are still some requirements in the FSMA regulations that apply to processors of the seafood, juice, and LACF products.”

FDA Sets Fees for Import and Facility Reinspections for FY18; Invoices Remain on Hold
August 1, 2017 |FDA

The Food and Drug Administration set potential fiscal year 2018 fees for import reinspections, domestic and foreign facility reinspections, and recall activities performed by FDA if a firm fails to comply with a mandatory recall order, though it still isn't invoicing for services associated with the fees, it said in a notice. The agency set FY18 fees of $248/hour for domestic services and $285/hour if foreign travel is required. The fees are effective Oct. 1.

Common Filing Issues Persist Despite Faster FDA Processing Times in ACE, FDA Official Says
August 1, 2017 |FDA

ACE has resulted in faster processing times for imports regulated by the Food and Drug Administration, but some filing issues persist, FDA import director Douglas Stearn said in a July 31 blog post. The proportion of entry lines receiving an automated “may proceed” has increased from 26 percent to 62 percent since adoption of the new system, and 28,374 fewer entry lines have needed additional documents and information. But a study of FDA rejections between November 2016 and March 2017 found that the most common filing problems were the submission of invalid or canceled food facility registration numbers and invalid FDA product codes, Stearn said. Other common filing issues may cause an entry to be rejected before ever making it to FDA for review, including incorrect syntax or omission of required affirmations of compliance, missing or invalid entity information, and missing or invalid units of measure, he said.