{"id":61598,"date":"2018-11-09T01:00:00","date_gmt":"2018-12-07T03:09:18","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/7fbf7e71a3\/"},"modified":"2018-12-07T11:09:19","modified_gmt":"2018-12-07T03:09:19","slug":"7fbf7e71a3","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/61598\/","title":{"rendered":"ANDA\u7533\u62a5\u8d39\u7528\u53ca\u652f\u4ed8"},"content":{"rendered":"
\n

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\"ANDA\u7533\u62a5\u8d39\u7528\u53ca\u652f\u4ed8\"<\/p>\n

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<\/p>\n

\u4e00\u3001ANDA\u7533\u62a5\u8d39\u7684\u77e5\u8bc6\u70b9<\/span><\/strong><\/p>\n

1. ANDA\u7533\u62a5\u8d39\u5728\u7533\u62a5\u8d44\u6599\u9012\u4ea4\u5f53\u5929\u5219\u89c6\u4e3a\u9700\u8981\u7f34\u7eb3\u3002FDA\u5728\u62d2\u6536\u6307\u5357\u4e2d\u5df2\u660e\u786e\u6307\u51fa\uff0c\u82e5\u7533\u8bf7\u4eba\u5728\u81ea\u7533\u62a5\u8d44\u6599\u9012\u4ea4\u540e20\u4e2a\u65e5\u5386\u65e5\u4e2d\uff0c\u672a\u6210\u529f\u7f34\u7eb3GDUFA ANDA\u6216PAS\u8d39\u7528\uff0c\u5219FDA\u4f1a\u505a\u51fa\u62d2\u6536\u51b3\u7b56\uff08Refuse-to-Receive\uff09\u3002<\/span><\/p>\n

2. ANDA\u9000\u5ba1\u540e\uff0cFDA\u4f1a\u9000\u56de75%\u5f53\u5e74\u8d22\u653f\u5e74\u7684\u7533\u62a5\u8d39\u3002<\/span><\/p>\n

3. \u82e5FDA\u4f9d\u636eFD&C Act section 505(j)(4)\u7ae0\u8282\u7684\u6761\u6b3e\u62d2\u6536ANDA\uff0c\u5219ANDA\u7533\u8bf7\u4eba\u5982\u679c\u6536\u53d675%\u7684\u9000\u6b3e\u8d39?<\/span><\/p>\n

\u7b54\uff1a\u7533\u8bf7\u4eba\u9700\u8981\u586b\u5199FDA 3913\u8868\u683c\u6216\u5c06FDA3913\u8868\u683c\u90ae\u4ef6\u53d1\u9001\u81f3<\/span><\/p>\n

CDERCollections@fda.hhs.gov \uff0c\u5305\u542b\u7a0e\u6536\u53f7\u7801\uff08Tax ID\uff09\uff08\u6240\u6709\u7f8e\u56fd\u56fd\u5185\u5236\u836f\u516c\u53f8\uff09\u6216DUNS\u53f7\u7801\uff08\u6240\u6709\u6d77\u5916\u5236\u836f\u516c\u53f8\uff09\u548c\u9000\u6b3e\u5730\u5740\u3002\u5982\u679c\u6ca1\u6709\u4e0a\u8ff0\u4fe1\u606f\uff0cFDA\u65e0\u6cd5\u5904\u7406\u9000\u6b3e\u3002\u4e3a\u4e86\u52a0\u901f\u9000\u6b3e\u6d41\u7a0b\uff0c\u5e94\u5728ANDA\u88ab\u62d2\u6536\u540e\u5c3d\u5feb\u63d0\u4ea4\u9000\u6b3e\u7533\u8bf7\u3002\u5982\u679c\u7533\u8bf7\u4eba\u672a\u9012\u4ea4\u9000\u6b3e\u7533\u8bf7\uff0c\u5219FDA\u5219\u4f1a\u8fdb\u884c\u5b9a\u671f\u5ba1\u9605\u672a\u507f\u4ed8\u9000\u6b3e\u7684\u7a0b\u5e8f\u6765\u542f\u52a8\u9000\u6b3e\u6d41\u7a0b\u3002\u4e5f\u53ef\u4ee5\u586b\u5199FDA 3914\u8868\u683c\u8981\u6c42FDA\u8f6c\u8d26\uff0c\u53ef\u5c06FDA 3914 \u6216Form FDA 3913\u8868\u683c\u90ae\u4ef6\u53d1\u9001\u81f3userfees@fda.gov\u6216\u8d1f\u8d23\u5ba1\u9605\u8be5ANDA\u7684\u9879\u76ee\u7ecf\u7406\u3002<\/span><\/p>\n

4. \u82e5\u9000\u6b3e\u7684ANDA\u91cd\u65b0\u9012\u4ea4\uff0c\u5219\u9700\u8981\u91cd\u65b0\u7f34\u7eb3\u5b8c\u6574\u7684\u7533\u62a5\u8d39\uff08Another full fee \uff09\u3002<\/span><\/p>\n

5. \u5bf9\u62d2\u6536\u4fe1\u7684\u56de\u590d\u4f55\u65f6\u4f1a\u89c6\u4e3a\u518d\u6b21\u9012\u4ea4\uff1f<\/span><\/p>\n

\u7b54\uff1a\u5bf9ANDA\u7684\u91cd\u65b0\u9012\u4ea4\u662f\u5bf9\u62d2\u6536\u51b3\u7b56\uff08RTR\uff09\u7684\u6b63\u5f0f\u56de\u590d\u3002\u9012\u4ea4\u6709\u5173RTR\u51b3\u7b56\u7684\u4e89\u8bba\u4e14\u672a\u5c1d\u8bd5\u5bf9\u7f3a\u9677\u8fdb\u884c\u4fee\u6b63\uff08\u5982\u4e0d\u518d\u6b21\u9012\u4ea4ANDA\uff09\uff0c\u4e0d\u89c6\u4e3a\u91cd\u65b0\u9012\u4ea4\uff0c\u65e0\u9700\u7f34\u7eb3\u7533\u62a5\u8d39\u7528\u3002<\/span><\/p>\n

6. \u672a\u6210\u529f\u7f34\u7eb3ANDA\u7533\u62a5\u8d39\uff0c\u5c06\u88ab\u89c6\u4e3a\u7533\u62a5\u8d44\u6599\u4e0d\u5b8c\u6574\u4e14\u4e0d\u4f1a\u88abFDA\u63a5\u6536\u3002<\/span><\/p>\n

7. \u5982\u679c\u5728FDA\u63a5\u6536\u7533\u62a5\u8d44\u6599\u4e4b\u524d\uff0cANDA\u7533\u8bf7\u4eba\u4e3b\u52a8\u63d0\u51fa\u64a4\u9500\u7533\u62a5\uff0c\u5219\u7533\u8bf7\u4eba\u53ef\u83b7\u53d675%\u7533\u62a5\u8d39\u7684\u9000\u6b3e\u3002<\/span><\/p>\n

8. \u5982\u679c\u7533\u62a5\u8d39\u652f\u4ed8\u4e4b\u524d\uff0cANDA\u7533\u8bf7\u4eba\u60f3\u8981\u64a4\u9500\u7533\u62a5\uff0c\u4ecd\u7136\u9700\u8981\u652f\u4ed8\u7533\u62a5\u8d39\u3002<\/span><\/p>\n

9. Generic Drug Submission\u6307\u7684\u662fANDA\u7533\u62a5\u3001ANDA\u7684\u53d1\u8865\u7533\u62a5\u548c\u4e8b\u5148\u6279\u51c6\uff08PAS\uff09\u7684\u8865\u5145\u7533\u62a5\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\u4e8c\u3001\u652f\u4ed8\u4fe1\u606f\u548cCover sheet<\/span><\/strong><\/span><\/p>\n

1. \u4f55\u65f6\u9700\u8981GDUFA Cover sheet?<\/span><\/p>\n

\u7b54\uff1a\u4e0b\u8ff0\u4eba\u7528\u836f\u7684\u4eff\u5236\u836f\u8d39\u7528\u9700\u8981GDUFA Cover sheet\uff1a<\/span><\/p>\n

1) \u4eff\u5236\u836f\u9879\u76ee\u8d39<\/span><\/p>\n

2) ANDA\u7533\u62a5\u8d39\u6216\u9002\u5b9c\u7684\u53d1\u8865\u8d39<\/span><\/p>\n

3)  II\u7c7bAPI DMF\u8d39\u7528\uff0c\u8fd9\u7c7bDMF\u57282012\u5e7410\u67081\u65e5\u540e\u5728\u5411FDA\u9012\u4ea4\u7684ANDA\u4e2d\u88ab\u53c2\u8003\u4e14\u975e\u652f\u4ed8\u8d39\u7528\uff1b<\/span><\/p>\n

4) \u4eff\u5236\u836f\u573a\u5730\u8d39\uff08API\u573a\u5730\u6216FDF\u573a\u5730\uff09\uff0c\u81f3\u5c11\u5728\u4e00\u4e2a\u672a\u6279\u51c6\u6216\u5df2\u6279\u51c6\u7684\u4eff\u5236\u836f\u7533\u62a5\u8d44\u6599\u4e2d\u4f53\u73b0\u3001\u7528\u4e8e\u751f\u4ea7\u4eba\u7528\u836f\u54c1\u7684\u573a\u5730\uff1b<\/span><\/p>\n

5) 2012\u5e7410\u67081\u65e5\u540e\u79ef\u538b\u3001\u4e14\u5728\u6b64\u4e4b\u524d\u672a\u6536\u5230\u4e34\u65f6\u6027\u6279\u51c6\u7684ANDA\uff1b<\/span><\/p>\n

 <\/span><\/p>\n

\u6ce8\uff1b\u5bf9\u4e8e\u6240\u6709ANDA\u6216PAS\u7684\u53d1\u8865\uff0c\u4e0d\u9700\u8981cover sheet\uff1b\u6839\u636eGDUFA\u6cd5\u4ee4\u7684Section 744B(a)(3)(F) fee\u7ae0\u8282\uff0c\u4ec5\u5bf9\u589e\u52a0API\u751f\u4ea7\u4fe1\u606f\u800c\u975e\u4ec5\u4ec5\u53c2\u8003\u5f15\u7528II\u7c7bDMF\u7684\u53d1\u8865\u9002\u7528\u3002<\/span><\/p>\n

 <\/span><\/p>\n

2. \u5982\u4f55\u586b\u5199GDUFA Cover sheet<\/span><\/p>\n

\u767b\u9646User Fee system\uff08\u4f7f\u7528\u8005\u8d39\u7528\u7cfb\u7edf\uff09\u586b\u5199\u4fe1\u606f\uff0c\u4ee5\u4fbf\u751f\u4ea7\u652f\u4ed8\u8d26\u5355\uff0c\u63d0\u4ea4\u540e\u5c31\u4f1a\u751f\u4ea7\u4ee5GD\u5b57\u6bcd\u6253\u5934\u7684\u4f7f\u7528\u8005\u8d39\u7528ID\u53f7\u7801\uff08a User Fee Payment I.D. Number (PIN)\uff09\u3002\u5728\u652f\u4ed8\u662f\u9700\u8981\u5f15\u7528PIN\u53f7\u7801\u3002https:\/\/userfees.fda.gov\/OA_HTML\/gdufaCAcdLogin.jsp<\/span><\/p>\n

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\u586b\u5199GDUFA Cover sheet\u6240\u9700\u4fe1\u606f\u5982\u4e0b\uff1a<\/span><\/p>\n

\uff081\uff09\u4e00\u822c\u4fe1\u606f<\/span><\/p>\n

\u7533\u8bf7\u4eba\/\u6301\u6709\u4eba\/\u6240\u6709\u4eba\u7684\u540d\u79f0\u3001\u5730\u5740\u548c\u8054\u7cfb\u4fe1\u606f\uff1b<\/span><\/p>\n

\u7f8e\u56fd\u4ee3\u7406\u7684\u540d\u79f0\u3001\u5730\u5740\u548c\u8054\u7cfb\u4fe1\u606f<\/span><\/p>\n

\uff082\uff09\u4eff\u5236\u836f\u9879\u76ee\u8d39\uff1a\u6bcd\u516c\u53f8\u540d\u79f0<\/span><\/p>\n

\uff083\uff09ANDA\uff1aFDA\u5206\u914d\u7684ANDA\u7533\u8bf7\u53f7\uff1b\u4ea7\u54c1\u5df2\u786e\u5b9a\u7684\u540d\u79f0\uff08\u82e5ANDA\u5305\u542bAPI\u7684\u751f\u4ea7\u4fe1\u606f\uff0c\u800c\u975e\u5355\u7eaf\u5730\u53c2\u8003\u5f15\u7528II\u7c7bDMF\uff0c\u5219\u7533\u8bf7\u4eba\u9700\u8981\u652f\u4ed8Section 744B(a)(2)(F)\u8d39\u7528\uff09<\/span><\/p>\n

\uff084\uff09II\u7c7bAPI DMF: FDA\u5206\u914d\u7684DMF\u53f7\u7801\uff1bAPI\u540d\u79f0<\/span><\/p>\n

\uff085\uff09\u573a\u5730\uff1a\u573a\u5730\u540d\u79f0\u3001\u5730\u5740\u3001FEI\u53f7\u7801\u548cDUNS\u53f7\u7801\uff1b\u786e\u8ba4\u8be5\u573a\u5730\u751f\u4ea7\u7684\u4eba\u7528\u836f\u54c1\u662f\u5426\u4e3a\u4eff\u5236\u836f\uff1b<\/span><\/p>\n

\uff086\uff09\u79ef\u538b\uff1aFDA\u5206\u914d\u7684ANDA\u7533\u8bf7\u53f7\uff1b\u4ea7\u54c1\u5df2\u786e\u5b9a\u7684\u540d\u79f0<\/span><\/p>\n

 <\/span><\/p>\n

\u652f\u4ed8\u8be6\u60c5\u5982\u4e0b\uff1a<\/span><\/p>\n

\uff081\uff09\u7535\u6c47\uff08Wire Transfer\uff09\u8be6\u60c5<\/span><\/p>\n

Bank Name | Telegraphic Name: \u8d26\u6237\u540d\u79f0<\/span><\/p>\n

U.S. Department of Treasury | TREAS NYC<\/span><\/p>\n

Bank Address: \u94f6\u884c\u5730\u5740<\/span><\/p>\n

33 Liberty Street | New York, NY 10045<\/span><\/p>\n

Account Number\uff08\u8d26\u6237\uff09: 75060099<\/span><\/p>\n

Routing Number\uff08\u8def\u5f84\u53f7\u7801\uff09: 021030004<\/span><\/p>\n

SWIFT Number\uff08\u94f6\u884c\u7f16\u53f7\uff09: FRNYUS33<\/span><\/p>\n

Beneficiary\uff08\u53d7\u76ca\u4eba\uff09: FDA | 8455 Colesville Road, COLE-14-14253| Silver Spring, MD 20993-0002<\/span><\/p>\n

Description\uff08\u6c47\u6b3e\u7559\u8a00\uff09: Reference the User Fee Payment I.D. Number (PIN)<\/span><\/p>\n

 <\/span><\/p>\n

\u6ce8\uff1a\u8f6c\u8d26\u8d39\u7528\u901a\u5e38\u572815\u81f335\u7f8e\u5143\u5de6\u53f3\uff0c\u901a\u5e38\u8981\u4fdd\u8bc1\u8fd9\u4e00\u7b14\u8d39\u7528\u4ee5\u786e\u4fdd\u4f7f\u7528\u8005\u8d39\u7528\u5b8c\u6574\u4e00\u6b21\u6027\u4ed8\u6e05\u3002<\/span><\/p>\n

 <\/span><\/p>\n

\uff082\uff09\u652f\u7968\u3001\u94f6\u884c\u6c47\u7968\u6216\u90ae\u653f\u6c47\u7968\uff08Check, Bank Draft, or U.S. Postal Money Order\uff09<\/span><\/p>\n

\u4ed8\u6b3e\u987b\u6ce8\u660e\u652f\u4ed8FDA\uff0c\u6807\u6ce8PIN\u53f7\u7801\u3002\u4ed8\u6b3e\u548c\u7b7e\u5b57\u7684Cover sheet\u5e94\u5bc4\u9001\u81f3\u4ee5\u4e0b\u5730\u5740\uff1a<\/span><\/p>\n

 <\/span><\/p>\n

Payments by mail:<\/span><\/p>\n

Food and Drug Administration<\/span><\/p>\n

P.O. Box 979108<\/span><\/p>\n

St. Louis, MO 63197-9000<\/span><\/p>\n

 <\/span><\/p>\n

Payments by courier<\/span><\/p>\n

U.S. Bank<\/span><\/p>\n

Attention: Government Lockbox 979108<\/span><\/p>\n

1005 Convention Plaza<\/span><\/p>\n

St. Louis, MO 63101<\/span><\/p>\n

 <\/span><\/p>\n

3. \u5c0f\u7ed3<\/span><\/strong><\/p>\n

\u9012\u4ea4ANDA\u7533\u62a5\u8d44\u6599\u540e\u5219\u88ab\u89c6\u4e3a\u6709\u4e49\u52a1\u9700\u8981\u5c65\u884cGDUFA\u4e49\u52a1\u548c\u7f34\u7eb3\u7533\u62a5\u8d39\u3002\u8d39\u7528\u7f34\u7eb3\u65f6\u95f4\u7a97\u53e3\u4e3a\u81ea\u7533\u62a5\u8d44\u6599\u9012\u4ea4\u540e\u768420\u5929\u5185\uff0c\u5426\u5219FDA\u62d2\u6536\u3002ANDA\u8d39\u7528\u7f34\u7eb3\u7684\u6d41\u7a0b\u4e3a\uff1a\u767b\u9646\u4f7f\u7528\u8005\u8d39\u7528\u7cfb\u7edf\u586b\u5199\u7533\u8bf7\u4eba\u6216\u4ee3\u7406\uff0c\u6709\u5173\u4ea7\u54c1\u3001\u573a\u5730\u7684\u76f8\u5173\u4fe1\u606f\uff0c\u5373\u586b\u5199 GDUFA Cover sheet\uff0c\u586b\u5199\u5b8c\u6210\u540e\u81ea\u52a8\u751f\u6210\u4f7f\u7528\u8005\u8d39\u7528ID\u53f7\u7801\uff0c\u5e76\u6839\u636eFDA\u63d0\u4f9b\u7684\u7535\u6c47\u652f\u4ed8\u6216\u652f\u7968\u7b49\u652f\u4ed8\u65b9\u5f0f\uff0c\u5c06\u5177\u4f53\u7684\u652f\u4ed8\u4fe1\u606f\u53cd\u9988\u7ed9\u94f6\u884c\u3002\u6ce8\u610f\u518d\u652f\u4ed8\u7533\u62a5\u8d39\u65f6\u9700\u8981\u652f\u4ed8\u4e00\u5b9a\u7684\u8f6c\u8d26\u8d39\u7528\u3002<\/span><\/p>\n

<\/span>
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\u5185\u5bb9\u6765\u6e90\uff1aAlma\u836f\u653f\u6cd5\u89c4\u89e3\u8bfb\uff0c\u7f16\u8f91\u6574\u7406<\/span><\/em><\/p>\n


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<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

\u4e00\u3001ANDA\u7533\u62a5\u8d39\u7684\u77e5\u8bc6\u70b9 1. ANDA\u7533\u62a5\u8d39\u5728\u7533\u62a5\u8d44\u6599\u9012\u4ea4\u5f53\u5929\u5219\u89c6\u4e3a\u9700\u8981\u7f34\u7eb3\u3002FDA\u5728\u62d2\u6536\u6307\u5357\u4e2d\u5df2\u660e\u786e\u6307\u51fa […]<\/p>\n","protected":false},"author":1,"featured_media":61599,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/61598"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=61598"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/61598\/revisions"}],"predecessor-version":[{"id":61601,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/61598\/revisions\/61601"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/61599"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=61598"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=61598"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=61598"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}