Follow-up Information

Furthermore, the substance or the preparation in which it is incorporated has to be handled only by customers staff in controlled conditions, and it must not be made available to the general public at any time either on its own or in a preparation. 

The one-year exemption period can be extended for an additional year under exceptional and reasonable circumstances. 

The notifier of a substance which was first notified by another manufacturer or importer should refer to the toxicological data in order to avoid duplicating testing on vertebrate animals. Therefore, the first notifier must give his agreement in writing to the reference to the results of the tests or studies before such a reference can be made. 

In order to reach an agreement on sharing the information, the competent authority will provide the prospective notifier with the name and address of the 

Any notifier of a substance already notified has to inform the competent authorities when the quantity of the substance placed on the market 

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The number on the outside of the case is required to be numeric or alphanumeric, not the name of the patient. Patient names are not permitted to be publicly disclosed in the context of a MedWatch report according to 21 CFR 21.63(f). The initial report is the first reported information received by the company about an individual s adverse drug experience. There must be a prompt attempt to obtain follow-up information about each initial report. The attempt(s) are made according to the company s written procedures. If the written safety procedures are not followed, the safety reports are not appropriately submitted, or the safety records are not appropriately kept, FDA has the authority under Section 80 of Part 315 to withdraw the market NDA. The follow-up report is the format for submitting additional information about an experience. Each case regards only one individual unless the experience is both temporally and clinically unrelated to a second event experienced by the same person taking the same drug product. 

If an initial 15-day report was submitted, and the first follow-up information reflects that the event is no longer classified as a 15-day report (never was serious and unexpected), the first follow-up report describes the change in the report classification but is a (first) follow-up 15-day report. Subsequent additional information is not submitted in the form of a 15-day report. 

The form can be printed as a folding postage prepaid envelope for domestic use to encourage a reply. The pharmaceutical company must be able to demonstrate due diligence in seeking relevant follow-up information on each AE report. 

Inspection of railcars, loading, and packing procedures Follow-up information to distributors warehouse personnel... 

Fifteen-day alert follow-up reports Applicants must report follow-up information on 15 -day reports as soon as possible, but in no case later than 15 calendar days of initial receipt of the information by the applicant. 

Serious adverse events that are seen in clinical trials and in the general use of marketed products need to be reported directly to a safety group or safety coordinator. Safety groups tend to operate and maintain their own databases for these SAE reports, or cases, because of the detailed information related to each case that they must collect (Prokscha, 2007). Each SAE case is initially entered in this system and then updated as follow-up information becomes available. 

Results of experimental studies in microorganisms and short-term experiments in laboratory animals suggest that long-term medical abnormalities in soldiers exposed to CS are unlikely. Acute tissue changes produced in animals and humans seem reversible and not likely to become chronic in the absence of recurrent exposures. Follow-up information on the long-term state of health of exposed soldiers is not available, but no reports indicate that Edgewood subjects have experienced any long-term sequelae. 

The proportion of members of each chemical-test group and comparison groups on whom follow-up information is obtained. 

This report is based on a follow-up of the 6,720 men who participated in experiments conducted by the Army at the Aberdeen Proving Ground, Edgewood, Maryland, in 1955-1975. Follow-up information was obtained from four sources ... 

Dermal/Ocular Effects. Schonning (1966) described a case of a 57- year-old man who accidentally spilled acrolein over his genital area. Swelling of the penis and scrotum occurred, and after 15 days the genital area was deeply ulcerated and gangrenous. No follow-up information was provided. Lacroix et al. (1976) applied a solution of 10% acrolein in ethanol to 12 volunteers the skin was biopsied 48 hours later. All subjects exhibited irritation and had papillary edema, and 11 had polymorphonuclear infiltrates. In addition, five cases of epidermal necrosis occurred. No further information was provided. 

A man and a woman developed vegetating plaques with peripheral pustules (halogenoderma) after taking lithium for 6 and 8 years respectively (410). No follow-up information was provided and it could not be established whether the lesions were caused by, worsened by, or unrelated to lithium. 

Cocaine use may account for up to 25% of acute myocardial infarctions among patients aged 18-45 years. The safety of a 12-hour observation period in a chest pain unit followed by discharge in individuals with cocaine-associated chest discomfort who are at low risk of cardiovascular events has been evaluated in 302 consecutive patients aged 18 years or older (66% men, 70% black, 84% tobacco users) who developed chest pain within 1 week of cocaine use or who tested positive for cocaine (59). Cocaine use was self-reported by 247 of the 302 subjects and rest had urine positive for cocaine 203 had used crack cocaine, 51 reported snorting, and 10 had used it intravenously. Of the 247 who reported cocaine use, 237 (96%) said they had used it in the week before presentation and 169 (68%) within 24 hours before presentation. Follow-up information was obtained for 300 subjects. There were no deaths from cardiovascular causes. Four patients had a non-fatal myocardial infarction during the 30-day period all four had continued to use cocaine. Of the 42 who were directly admitted to hospital, 20 had acute coronary syndrome. The authors suggested that in... 

This treatise includes 146 figures, 17 worked out examples and 37 tables (many of which contain valuable collections of data and references). Each of the nine chapters cites extensive references, including very recent papers where the reader can follow up information in more detail. 

All relevant information on suspected unexpected serious adverse reactions (SARs) considered life threatening or fatal must be reported to CA in all MS and to the IEC as soon as possible or within 7 days of the sponsor learning of them and all follow-up information within a further 8 days. All other reactions are to be advised within 15 days of knowledge by the sponsor. Member States are responsible for recording all SARs and sponsors for advising all investigators. 

Monsanto, Follow-Up Information The One-Generation Reproduction Study in Rats with Elemental Phosphorus with Attachments and Cover Letter Dated 080591, Monsanto Co., EPAOTS0518525-4, 1991. 

The major criterion for filing a report is belief or evidence that a serious adverse reaction has occurred (Henkel, 1999). Generally, the type of reaction to report is one that was not evident during initial drug trials and was not expected to be a common side effect and, therefore, does not appear in the product handout. The reporter is not required to demonstrate or substantiate an actual reaction, yet the reporter needs to believe it has occurred and that future incidents are possible. Since the FDA will probably ask for technical follow-up information on each of these reports, it prefers that a trained health care professional, rather than a client, make the actual reports. A post-marketing safety evaluator examines information from MedWatch reports, and according to Henkel (1999) once the adverse effect has been identified the FDA can take the following actions ... 

The Commission has promulgated elaborate and detailed regulatons governing the submission of substantial risk reports. See 16 C.F.R., Part 1115. These regulations also discuss the submission of follow-up information and the negotiation of voluntary corrective action. 

A speciality TMA is designed with a specific project in mind. These TMAs suffer from the major drawback that they require a significant investment of time and effort for a single project. An alternative solution to the customized TMA construction approach is a modular approach, where existing TMAs can be used to complement each other. Another important concern is the utilization of scarce resources. This is specifically significant when evaluating cases with extensive follow-up information as well as foci of metastatic disease. Metastatic tissue samples are not readily available in department of pathology archival materials, and they should be used only for validated projects. 

Dermal/Ocular Effects. Very limited information is available regarding dermal/ocular effects after inhalation exposure to MBOCA. When a worker was accidentally sprayed with molten MBOCA, he experienced burning of the face and eyes shortly thereafter (Hosein and Van Roosmalen 1978). The worker was wearing gloves and safety glasses but no respirator or face shield, so the exposure may have occurred by ingestion or dermal absorption as well. The limitations of this study are (1) no further follow-up information was provided on the worker s condition (2) the dose of MBOCA was not known (3) exposure involved mixed routes and (4) only one exposed individual was described. 

The sponsor monitor is responsible for the timely follow-up of all serious adverse events. The cases must be followed to completion. The monitor needs to collect all required follow-up information on ADEs. 

Warranty information and records may be included as a separate module or within this module, coded by vendor with description of warranties and warranty coverage. May include printmg of exception reports, warranty claims and follow-up information. 

In mid-1922, the MICC requested and obtained fi om the IG its final sets of plant survey forms and questionnaires. In some cases it also requested follow-up information, which IG firms also supplied. The information covered explosives (nitrocellulose and nitroglycerine propellants, TNT, picric acid, and a host of other nitrogenous substitute high explosives), as well as the principal chemical warfare agents. 

In-market follow-up information must be assessed for each area of function reviewed, as appropriate. Level 2 assessments are recommended when any one of the following conditions occurs ... 

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