Post Marketing Study Status and Annual Reporting - the REGS
May 5, 2015 19:08:36 GMT -5
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Post by Deleted on May 5, 2015 19:08:36 GMT -5
Ok, so this is how I spend my investment research time and the three posts with some of the info I've accumulated as it relates to afrezza is where I've been focusing my energy for the last few weeks. I have a lot more but I suspect I've bored just about everyone with these posts, so, enjoy better sleep at night while trying to read this stuff......lol
Pharma has to report to the FDA annually and this is what they have to include in their report (below) for FDA approved medications. I haven't tried to search for other companies reports, but, since SNY and MNKD are so tight lipped, I"m wondering if we won't be able to do a FOI request and obtain this report (if it's not made public). It's not national security, but, there may be a rule that pharma can use to keep their reports confidential for competitive reasons. However, if not, it might provide more information than we would ever hear directly. But that's a leap at the moment as I'm not sure.
PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart B--Applications
Sec. 314.81 Other postmarketing reports.
The annual reporting requirement is:
(2) Annual report. The applicant shall submit each year within 60 days of the anniversary date of U.S. approval of the application, two copies of the report to the FDA division responsible for reviewing the application. Each annual report is required to be accompanied by a completed transmittal Form FDA 2252 (Transmittal of Periodic Reports for Drugs for Human Use), and must include all the information required under this section that the applicant received or otherwise obtained during the annual reporting interval that ends on the U.S. anniversary date.
The report requirement as it relates to postmarketing study commitments:
(vii) Status reports of postmarketing study commitments. A status report of each postmarketing study of the drug product concerning clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology that is required by FDA (e.g., accelerated approval clinical benefit studies, pediatric studies) or that the applicant has committed, in writing, to conduct either at the time of approval of an application for the drug product or a supplement to an application, or after approval of the application or a supplement. For pediatric studies, the status report shall include a statement indicating whether postmarketing clinical studies in pediatric populations were required by FDA under 201.23 of this chapter. The status of these postmarketing studies shall be reported annually until FDA notifies the applicant, in writing, that the agency concurs with the applicant's determination that the study commitment has been fulfilled or that the study is either no longer feasible or would no longer provide useful information.
(a ) Content of status report. The following information must be provided for each postmarketing study reported under this paragraph:
(1 ) Applicant's name.
(2 ) Product name. Include the approved drug product's established name and proprietary name, if any.
(3 ) NDA, ANDA, and supplement number.
(4 ) Date of U.S. approval of NDA or ANDA.
(5 ) Date of postmarketing study commitment.
(6 ) Description of postmarketing study commitment. The description must include sufficient information to uniquely describe the study. This information may include the purpose of the study, the type of study, the patient population addressed by the study and the indication(s) and dosage(s) that are to be studied.
(7 ) Schedule for completion and reporting of the postmarketing study commitment. The schedule should include the actual or projected dates for submission of the study protocol to FDA, completion of patient accrual or initiation of an animal study, completion of the study, submission of the final study report to FDA, and any additional milestones or submissions for which projected dates were specified as part of the commitment. In addition, it should include a revised schedule, as appropriate. If the schedule has been previously revised, provide both the original schedule and the most recent, previously submitted revision.
(8 ) Current status of the postmarketing study commitment.
Pharma has to report to the FDA annually and this is what they have to include in their report (below) for FDA approved medications. I haven't tried to search for other companies reports, but, since SNY and MNKD are so tight lipped, I"m wondering if we won't be able to do a FOI request and obtain this report (if it's not made public). It's not national security, but, there may be a rule that pharma can use to keep their reports confidential for competitive reasons. However, if not, it might provide more information than we would ever hear directly. But that's a leap at the moment as I'm not sure.
PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart B--Applications
Sec. 314.81 Other postmarketing reports.
The annual reporting requirement is:
(2) Annual report. The applicant shall submit each year within 60 days of the anniversary date of U.S. approval of the application, two copies of the report to the FDA division responsible for reviewing the application. Each annual report is required to be accompanied by a completed transmittal Form FDA 2252 (Transmittal of Periodic Reports for Drugs for Human Use), and must include all the information required under this section that the applicant received or otherwise obtained during the annual reporting interval that ends on the U.S. anniversary date.
The report requirement as it relates to postmarketing study commitments:
(vii) Status reports of postmarketing study commitments. A status report of each postmarketing study of the drug product concerning clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology that is required by FDA (e.g., accelerated approval clinical benefit studies, pediatric studies) or that the applicant has committed, in writing, to conduct either at the time of approval of an application for the drug product or a supplement to an application, or after approval of the application or a supplement. For pediatric studies, the status report shall include a statement indicating whether postmarketing clinical studies in pediatric populations were required by FDA under 201.23 of this chapter. The status of these postmarketing studies shall be reported annually until FDA notifies the applicant, in writing, that the agency concurs with the applicant's determination that the study commitment has been fulfilled or that the study is either no longer feasible or would no longer provide useful information.
(a ) Content of status report. The following information must be provided for each postmarketing study reported under this paragraph:
(1 ) Applicant's name.
(2 ) Product name. Include the approved drug product's established name and proprietary name, if any.
(3 ) NDA, ANDA, and supplement number.
(4 ) Date of U.S. approval of NDA or ANDA.
(5 ) Date of postmarketing study commitment.
(6 ) Description of postmarketing study commitment. The description must include sufficient information to uniquely describe the study. This information may include the purpose of the study, the type of study, the patient population addressed by the study and the indication(s) and dosage(s) that are to be studied.
(7 ) Schedule for completion and reporting of the postmarketing study commitment. The schedule should include the actual or projected dates for submission of the study protocol to FDA, completion of patient accrual or initiation of an animal study, completion of the study, submission of the final study report to FDA, and any additional milestones or submissions for which projected dates were specified as part of the commitment. In addition, it should include a revised schedule, as appropriate. If the schedule has been previously revised, provide both the original schedule and the most recent, previously submitted revision.
(8 ) Current status of the postmarketing study commitment.
