Center for Food Safety and Applied Nutrition
Constituent Update
The following is an update from the FDA Center for Veterinary Medicine of interest to the CFSAN Constituent Update subscribers.
FDA Requests Comments on Documents Related to Certain Biotechnology and Mosquito-related Products
January 18, 2016
The U.S. Food and Drug Administration released today three documents for public comment about steps the agency is taking to clarify its regulation of certain biotechnology and mosquito-related products.
The FDA is requesting public comment on a draft revised guidance on the regulation of animals with intentionally altered genomic DNA, including animals produced through the use of genome editing and genetic engineering; a request for comment related to the regulation of foods from plants produced using genome editing technologies; and a draft guidance that clarifies which mosquito-related products FDA regulates and which such products EPA regulates, regardless of whether these mosquito-related products are developed using biotechnology.
These announcements are consistent with the FDA’s commitments outlined in the National Strategy for Modernizing the Regulatory System for Biotechnology Products (the Strategy; released in September 2016), which sets forth a vision for ensuring that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology.
Draft guidance for industry on intentionally altered genomic DNA in animals In the Strategy, the FDA noted its intent to clarify how developers of animals produced using emerging technologies, including genome editing, may meet applicable statutory and regulatory requirements. Consistent with this commitment, FDA is issuing draft revised Guidance for Industry #187, Regulation of Intentionally Altered Genomic DNA in Animals, for public comment.
The draft revised guidance clarifies that the FDA generally regulates animals with intentionally altered genomic DNA, including genetically engineered animals, under the new animal drug provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act, because, unless otherwise excluded, altered genomic DNA in an animal that is intended to affect the structure or function of the body of that animal meets the definition of a drug. The requirements and recommendations for developers of these animals are outlined in the draft revision.
The FDA encourages public comments on draft revised guidance #187 during the 90-day comment period, as well as on several questions the agency posed in the notice of availability announcing the guidance in the Federal Register. These questions concern appropriate terminology, and whether scientific evidence demonstrates that there are categories of intentional alterations of genomic DNA in animals that pose low to no significant risk. Public comments will be accepted starting on January 19, 2017.
Request for comment on the use of genome editing in plants intended for food As part of the agency’s implementation of the Strategy, the FDA is seeking public input to help inform its regulatory approach to human and animal foods derived from plants developed using genome editing. The agency is seeking scientific evidence and other factual information on specific questions during a 90-day comment period. Comments received will help inform the FDA’s thinking on human and animal foods derived from new plant varieties produced using genome editing.
Any company looking to market foods is responsible for complying with all applicable laws and regulations. Foods from new plant varieties must meet the same food safety requirements under the FD&C Act, regardless of how the new varieties are produced. For more than 20 years, developers have routinely consulted FDA about the safety and regulatory status of foods from new genetically engineered plant varieties prior to marketing. The FDA intends to continue offering consultations for developers of new plant varieties, including those produced using genome editing, in order to help developers ensure that applicable safety and legal questions are resolved prior to marketing.
The agency is accepting public comment on this issue for 90 days starting on January 19, 2017.
Draft guidance for industry on mosquito-related products As part of the Strategy, the FDA and EPA committed to considering mechanisms that would enable EPA to regulate certain mosquito-related products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) when the developer claims they are intended to control mosquito population levels, and the FDA to regulate them under the FD&C Act when the developer makes other claims, such as a disease prevention claim.
The FDA’s draft Guidance for Industry #236, developed in coordination with EPA, describes the FDA’s understanding that mosquito-related products intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for population control purposes are not “drugs” under the FD&C Act, and, when the guidance is finalized, will be regulated by EPA under FIFRA. Under the draft guidance, FDA would continue to have jurisdiction over mosquito-related products that meet the FD&C Act drug definition, such as those intended to prevent, treat, or cure a disease.
The FDA encourages public comments on draft guidance #236 for 30 days starting on January 19, 2017. These activities, together with the recent release of the final 2017 Update to the Coordinated Framework for the Regulation of Biotechnology, are part of an ongoing effort to modernize the regulatory system for biotechnology products.
The FDA is accepting public comments on these documents beginning on January 19, 2017. To electronically submit comments to the docket, visit www.regulations.gov and use the docket numbers listed below.
To submit comments to the docket by mail, use the following address. Be sure to include the appropriate docket number on each page of your written comments.
Division of Dockets Management HFA-305 Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852
Comments will be accepted at any time, but should be submitted no later than the closing date to ensure that the FDA takes the information into consideration before making further decisions on this issue.
Draft revised GFI #187: Regulation of Intentionally Altered Genomic DNA in Animals, Docket Number FDA-2008-D-039, closes on April 19, 2017
Request for Comments: Genome Editing in New Plant Varieties Used For Foods, Docket Number FDA-2016-N-4389, closes on April 19, 2017
Draft GFI #236: Regulation of Mosquito-Related Products, Docket Number FDA-2016-D-4482, closes on February 21, 2017
January 18, 2017
The U.S. Food and Drug Administration and the U.S. Environmental Protection Agency issued advice regarding fish consumption. This advice is geared toward helping women who are pregnant or may become pregnant – as well as breastfeeding mothers and parents of young children – make informed choices when it comes to fish that is healthy and safe to eat. (This advice refers to fish and shellfish collectively as “fish.”)
To help consumers more easily understand the types of fish to select, the agencies have created an easy-to-use reference chart that sorts 62 types of fish into three categories:
--“Best Choices” (eat two to three servings a week)
--“Good Choices” (eat one serving a week)
--“Fish to Avoid”
Fish in the “Best Choices” category make up nearly 90 percent of fish eaten in the United States.
An FDA analysis of fish consumption data found that 50 percent of pregnant women surveyed ate fewer than 2 ounces a week, far less than the amount recommended. Because the nutritional benefits of eating fish are important for growth and development during pregnancy and early childhood, the agencies are advising and promoting a minimum level of seafood consumption for these groups. The advice recommends 2 to 3 servings of lower-mercury fish per week, or 8 to 12 ounces. However, all fish contain at least traces of mercury, which can be harmful to the brain and nervous system if a person is exposed to too much of it over time. The maximum level of consumption recommended in the final advice is consistent with the previous recommended level of 12 ounces per week. The new advice is consistent with the 2015 - 2020 Dietary Guidelines for Americans.
For adults, a typical serving is 4 ounces of fish, measured before cooking. Serving sizes for children should be smaller and adjusted for their age and total calorie needs. It is recommended that children eat fish once or twice a week, selected from a variety of fish types.
For additional information:
- Eating Fish: What Pregnant Women and Parents Should Know (FDA/EPA's advice regarding fish consumption)
- Federal Register Notice Announcing the Advice
What's New on the FDA Drugs Site
January 17, 2017
- CDER Drug Statement: FDA approves a generic of Xyrem with a REMS Program
- 2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry (PDF - 82KB)
- FDA Drug Shortages
- Alitretinoin (Panretin) Gel (New - Currently in Shortage)
- Cefepime Injection (New - Currently in Shortage)
- Tobramycin Injection (Updated - Currently in Shortage)
- From our perspective: Interchangeable biological products
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Timolol GFS 0.25% and 0.5%: Clinical Review (PDF - 775KB) andWritten Request (PDF -110KB)
- Assessment of Abuse Potential of Drugs Guidance for Industry (PDF - 285KB)
- Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry (PDF - 229KB)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers Guidance for Industry (PDF - 134KB)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting(updated)
New and Generic Drug Approvals
January 13, 2017
| Drug Name and Application Number | Active Ingredient | Dosage Form/ Route | Submission | Company | Submission Classification | Submission Status |
|---|---|---|---|---|---|---|
| Codeine Phosphate and Chlorpheniramine Maleate NDA #206323 | Chlorpheniramine Maleate; Codeine Phosphate | Tablet, Extended Release; Oral | SUPPL-4 | Spriaso Llc | LABELING | Approved |
| Cordran NDA #016455 | Flurandrenolide | Tape; Topical | SUPPL-25 | Allergan Sales Llc | MANUF (CMC) | Approved |
| Flowtuss NDA #022424 | Guaifenesin; Hydrocodone Bitartrate | Solution; Oral | SUPPL-1 | Mission Pharmacal Co | LABELING | Approved |
| Fluoxetine Hydrochloride ANDA #076024 | Fluoxetine Hydrochloride | Tablet; Oral | SUPPL-4 | Sandoz | LABELING | Approved |
| Homatropine Methylbromide and Hydrocodone Bitartrate ANDA #040295 | Homatropine Methylbromide; Hydrocodone Bitartrate | Tablet; Oral | SUPPL-8 | Actavis Elizabeth | LABELING | Approved |
| Homatropine Methylbromide and Hydrocodone Bitartrate ANDA #091528 | Homatropine Methylbromide; Hydrocodone Bitartrate | Tablet; Oral | SUPPL-1 | Novel Labs Inc | LABELING | Approved |
| Hycodan NDA #005213 | Homatropine Methylbromide; Hydrocodone Bitartrate | Syrup; Oral | SUPPL-38 | Endo Pharms | LABELING | Approved |
| Hycodan NDA #005213 | Homatropine Methylbromide; Hydrocodone Bitartrate | Tablet; Oral | SUPPL-38 | Endo Pharms | LABELING | Approved |
| Hycofenix NDA #022279 | Guaifenesin; Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride | Solution; Oral | SUPPL-1 | Mission Pharmacal Co | LABELING | Approved |
| Hydrocodone Bitartrate and Homatropine Methylbromide ANDA #040613 | Homatropine Methylbromide; Hydrocodone Bitartrate | Syrup; Oral | SUPPL-9 | Hi Tech Pharma | LABELING | Approved |
| Hydrocodone Bitartrate and Homatropine Methylbromide ANDA #088008 | Homatropine Methylbromide; Hydrocodone Bitartrate | Syrup; Oral | SUPPL-17 | Wockhardt | LABELING | Approved |
| Hydrocodone Bitartrate and Homatropine Methylbromide ANDA #088017 | Homatropine Methylbromide; Hydrocodone Bitartrate | Syrup; Oral | SUPPL-48 | Actavis Mid Atlantic | LABELING | Approved |
| Librax NDA #012750 | Chlordiazepoxide Hydrochloride; Clidinium Bromide | Capsule; Oral | SUPPL-65 | Valeant Pharms | LABELING | Approved |
| Lidocaine Hydrochloride 0.2% and Dextrose 5% In Plastic Container NDA #019830 | Lidocaine Hydrochloride | Injectable; Injection | SUPPL-20 | B Braun | MANUF (CMC) | Approved |
| Lidocaine Hydrochloride 0.4% and Dextrose 5% In Plastic Container NDA #019830 | Lidocaine Hydrochloride | Injectable; Injection | SUPPL-20 | B Braun | MANUF (CMC) | Approved |
| Lidocaine Hydrochloride 0.8% and Dextrose 5% In Plastic Container NDA #019830 | Lidocaine Hydrochloride | Injectable; Injection | SUPPL-20 | B Braun | MANUF (CMC) | Approved |
| Methotrexate Sodium ANDA #207812 | Methotrexate Sodium | Tablet; Oral | ORIG-1 | Zydus Pharms Usa Inc | Approved | |
| Obredon NDA #205474 | Guaifenesin; Hydrocodone Bitartrate | Solution; Oral | SUPPL-3 | Sovereign Pharms | LABELING | Approved |
| Phenergan Vc W/ Codeine NDA #008306 | Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride | Syrup; Oral | SUPPL-32 | Ani Pharms | LABELING | Approved |
| Phenergan W/ Codeine NDA #008306 | Codeine Phosphate; Promethazine Hydrochloride | Syrup; Oral | SUPPL-32 | Ani Pharms | LABELING | Approved |
| Piperacillin and Tazobactam ANDA #207847 | Piperacillin Sodium; Tazobactam Sodium | Injectable; Injection | ORIG-1 | Apollo Pharms Inc | Approved | |
| Piperacillin and Tazobactam ANDA #207848 | Piperacillin Sodium; Tazobactam Sodium | Injectable; Injection | ORIG-1 | Apollo Pharms Inc | Approved | |
| Piperacillin; Tazobactam ANDA #207848 | Piperacillin;Tazobactam | Injectable; Injection | ORIG-1 | Apollo Pharms Inc | Approved | |
| Prometh Hydrochloride,Phenylephrine Hydrochloride W/Codeine Phosphate ANDA #040660 | Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride | Syrup; Oral | SUPPL-19 | Vintage | LABELING | Approved |
| Prometh Vc W/ Codeine ANDA #088764 | Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride | Syrup; Oral | SUPPL-85 | Actavis Mid Atlantic | LABELING | Approved |
| Promethazine Hydrochloride and Codeine Phosphate ANDA #040151 | Codeine Phosphate; Promethazine Hydrochloride | Syrup; Oral | SUPPL-15 | Hi Tech Pharma | LABELING | Approved |
| Promethazine Hydrochloride and Codeine Phosphate ANDA #088763 | Codeine Phosphate; Promethazine Hydrochloride | Syrup; Oral | SUPPL-86 | Actavis Mid Atlantic | LABELING | Approved |
| Promethazine Hydrochloride and Codeine Phosphate ANDA #088875 | Codeine Phosphate; Promethazine Hydrochloride | Syrup; Oral | SUPPL-37 | Wockhardt | LABELING | Approved |
| Promethazine Hydrochloride and Codeine Phosphate ANDA #089647 | Codeine Phosphate; Promethazine Hydrochloride | Syrup; Oral | SUPPL-11 | Pharm Assoc | LABELING | Approved |
| Promethazine Hydrochloride and Codeine Phosphate ANDA #090180 | Codeine Phosphate; Promethazine Hydrochloride | Syrup; Oral | SUPPL-6 | Nostrum Labs Inc | LABELING | Approved |
| Promethazine Hydrochloride and Codeine Phosphate ANDA #200386 | Codeine Phosphate; Promethazine Hydrochloride | Syrup; Oral | SUPPL-3 | Tris Pharma Inc | LABELING | Approved |
| Promethazine Hydrochloride and Codeine Phosphate ANDA #200894 | Codeine Phosphate; Promethazine Hydrochloride | Syrup; Oral | SUPPL-1 | Amneal Pharms | LABELING | Approved |
| Promethazine Hydrochloride, Phenylephrine Hydrochloride W/Codeine Phosphate ANDA #040674 | Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride | Syrup; Oral | SUPPL-2 | Hi-Tech Pharma Co | LABELING | Approved |
| Promethazine Hydrochloride,Phenylephrine Hydrochloride W/Codeine Phosphate ANDA #200963 | Codeine Phosphate; Phenylephrine Hydrochloride; Promethazine Hydrochloride | Syrup; Oral | SUPPL-1 | Amneal Pharms | LABELING | Approved |
| Promethazine Hydrochloride; Codeine Phosphate ANDA #090180 | Promethazine Hydrochloride; Codeine Phosphate | Syrup; Oral | SUPPL-6 | Nostrum Labs Inc | LABELING | Approved |
| Promethazine With Codeine ANDA #040650 | Codeine Phosphate; Promethazine Hydrochloride | Syrup; Oral | SUPPL-17 | Vintage | LABELING | Approved |
| Rezira NDA #022442 | Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride | Solution; Oral | SUPPL-9 | Cypress Pharm | LABELING | Approved |
| Saphris NDA #022117 | Asenapine Maleate | Tablet; Sublingual | SUPPL-20 | Forest Labs Llc | LABELING | Approved |
| Saphris NDA #022117 | Asenapine Maleate | Tablet; Sublingual | SUPPL-21 | Forest Labs Llc | LABELING | Approved |
| Soliris BLA #125166 | Eculizumab | Injectable; Iv (Infusion) | SUPPL-417 | Alexion Pharm | LABELING | Approved |
| Triacin-C ANDA #088704 | Codeine Phosphate; Pseudoephedrine Hydrochloride; Triprolidine Hydrochloride | Syrup; Oral | SUPPL-34 | Sti Pharma Llc | LABELING | Approved |
| Tussigon ANDA #088508 | Homatropine Methylbromide; Hydrocodone Bitartrate | Tablet; Oral | SUPPL-18 | King Pharms | LABELING | Approved |
| Tussionex Pennkinetic NDA #019111 | Chlorpheniramine Polistirex; Hydrocodone Polistirex | Suspension, Extended Release; Oral | SUPPL-19 | Ucb Inc | LABELING | Approved |
| Tuzistra Xr NDA #207768 | Chlorpheniramine Polistirex; Codeine Polistirex | Suspension, Extended Release; Oral | SUPPL-4 | Vernalis R and D Ltd | LABELING | Approved |
| Vituz NDA #204307 | Chlorpheniramine Maleate; Hydrocodone Bitartrate | Solution; Oral | SUPPL-3 | Cypress Pharm | LABELING | Approved |
| Zutripro NDA #022439 | Chlorpheniramine Maleate; Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride | Solution; Oral | SUPPL-9 | Cypress Pharm | LABELING | Approved |
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