FDA WILL PERMIT INVESTIGATIONAL DRUG/BIOLOGIC EXPORTS of products without INDs after requests from either mfrs. or foreign govts., the agency announced in a Jan. 17 Federal Register notice. The rule, which is effective immediately, implements a change proposed by the agency last June in the IND rewrite ("The Pink Sheet" June 13, p. 7). Under the new policy, mfrs. seeking to export unapproved products not subject to INDs must: provide the agency with "sufficient information" to satisfy FDA that the agent is appropriate for investigational use assure FDA that it will be used "for investigational purposes only" assure that the product can be legally used by the "consignee in the importing country for the proposed investigational use." A foreign govt. official submitting a request must specify that the govt. has "adequate information" about both the product and the proposed use, the product will be used only for investigational purposes, and the drug or biologic can legally be used in the importing country. The new regs permit foreign govts. to make requests for investigational product imports directly to FDA, rather than through the State Dept. However, under both procedures, "FDA will continue to coordinate the export of unapproved drugs with the Dept. of State," the notice explained. The change in the export provision was initially prompted by Genentech. The firm had been seeking to export investigational drug material to Japan, but was unable to secure a letter, required by the previous regs, from the Japanese govt. In reponse to a comment FDA stressed that a firm must receive agency authorization before exporting an unapproved product that lacks an IND. The comment urged that FDA adopt the procedure used for export authorization of IND porducts, under which the request is considered granted if the FDA fails to respond within a specific time period. "FDA believes that it is appropriate to insist that the export of an investigational drug be conditioned on the receipt of an affirmative agency response authorizing such export," the preamble said. "Requiring affirmative agency response ensures that an inappropriate export request will not be authorized through an inadvertent failure to act." The agency asserted that the information required for an export request "should usually not represent a significant burden to the exporting company, and will often involve less information than would be required to obtain an IND." FDA said, however, it is willing to discuss specific requirements with mfrs. "on a case-by-case basis."
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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