GlobalVigiPub provides you the free online pharmacovigilance training via the posts page on our website. This Guidance on drug safety is good enough to understand the Pharmacovigilance basics and get the roots of pharmacovigilance in detailed too. Just browse the posts and read to get the knowledge on Pharmacovigilance course
US – FDA Pharmacovigilance Complete Guidance
Q: What are regulations for MAH (Marketing Authorization Holder) in USA for Postmarketing Reporting of Adverse Drug Experiences?
A: Adverse drug experiences must be reported by MAH in USA in accordance with the requirements of 21 CFR 310.305 and 314.80.
Those regulations require three types of ADE reports
- 15-day reports of serious, unlabeled events
- 15-day narrative increased frequency reports of serious, labeled events
- Periodic reports.
Readers Note: if you really wants to rid of Alcohol, Just 7 Days to Drink less. Join in Online Alcohol Reduction Program, Alcohol Free Forever
Q: Who must report?
A: The manufacturer or applicant is required to report. In addition, any person whose name appears on the label of a marketed drug as its manufacturer, packer, or distributor has reporting responsibilities, as does the individual or corporate entity that holds an approved new drug application (NDA), abbreviated new drug application (ANDA), or antibiotic application.
Applicants (individual or corporate entity that holds an NDA or ANDA or BLA) are required to submit postmarketing safety reports to the FDA for human drug products with approved NDAs as per (314.80) and ANDAs as per (314.98) and BLA as per 600.80 and 600.81.
Any person whose name appears on the label of a licensed biological product as its manufacturer, packer, distributor, shared manufacturer, joint manufacturer, or any other participant involved in divided manufacturing has postmarketing safety reporting responsibilities (600.80(c)(1)(iii)).
Readers Note: Intensive Stretch Mark Therapy with Skinception is noted treatment for years to come.
Q: What to report in USA as per FDA?
A: Reporting scenarios
- All reports of spontaneous adverse events occurring within the United States (domestic reports)
- Foreign, literature, and study reports involving
- Serious, unlabeled events
- Increased frequency of serious, labeled events.
- Study reports must only be submitted if there is a reasonable possibility that the drug caused the adverse experience. The study reports regulation are presented in (21 CFR 310.305(c) (1) (ii) and 21 CFR 314.80(e) (1))).
Readers Note: Fight Back against Viruses and Inflammation and Promote Proper Immune System Function with Extract of Curcumin 2000
Serious and unexpected adverse experiences from all sources (domestic and foreign) as ICSRs. Possible sources include, for example, scientific literature, post-marketing studies, or commercial marketing experience.
Spontaneously reported adverse experiences that occur domestically and that are Serious and expected, Non-serious and unexpected, Non-serious and expected need to be included in PADERs.
Adverse experiences from studies must only be submitted to the FDA if the applicant believes that there is a reasonable possibility that the drug or biological product caused the adverse experience (see 310.305(c)(1)(ii), 314.80(e)(1) and 600.80(e)(1)).
Readers Note: A product is considered as standout product in the hair regrowth industry. Profollica can regenerate the follicular growth which results your hair back
Readers Note: Provillus Hair Loss Treatment. Why more people are turning to it to prevent hair loss for MEN, for WOMEN and regrow hair with the only FDA approved ingredient on the market
Q: What is mandatory for MAH to do when an applicant receives information that should be submitted in a 15-day report, but it is not possible to provide all the desired information in that?
A: In this scenario, a preliminary report must be submitted with available information by that time within 15 days. Additional follow-up information must be sought and submitted within 15 working days after obtaining the new information. If additional relevant information is not obtained, then the documentation of the procedure followed in seeking to obtain the additional information should be maintained. FDA may request this documentation.
Readers Note: Natural support for your cholesterol. The Hypercet cholesterol Formula acts as a general tonic supporting the cardiovascular system. Supports good and bad cholesterol levels within the normal range along with the ability to deal with harmful free radicals
Q: How to submit Periodic Reports and what is timeframe for this?
A: Periodic reports are required for each approved NDA, ANDA, and antibiotic application. Periodic reports are due quarterly for the first 3 years after approval, and annually thereafter. Periodic reports due quarterly must be submitted within 30 days of the last day of the reporting quarter. Reports due annually must be submitted each year within 60 days of the anniversary date of approval of the drug.
Readers Note: If you would like to Quit Smoking? Really it’s a Magic. Get it with Stop Smoking Program, Smoke-free just in short span
Q: How MAH need to deal with Overdose reports?
A: Reports of overdose should be submitted only when the overdose was associated with an adverse event. If the adverse experience associated with the overdose is serious and unexpected, a l5-day report should be completed. If the adverse experience is serious and expected, nonserious and unexpected, or nonserious and expected, a non-15 day report should be submitted in the periodic report.
Q: Is it necessary for MAH to protect the patient data?
A: It is of critical importance to protect patients and their privacy during the generation of safety data.
Readers Note: The clinically proven and natural premium fitness supplements as PrimeGENIX for men over 40 who want to get in shape and have more energy
Q: MAH need to do follow-up for cases?
A: FDA recommends that sponsors make a reasonable attempt to obtain complete information for case assessment during initial contacts and subsequent follow-up, especially for serious events.
Q: What is FAERS and VAERS?
A: FDA’s Adverse Event Reporting System (FAERS) or Vaccine Adverse Events Reporting System (VAERS).
Readers Note: Try this unique eyelash growth serum Idol Lash that will help you achieve Longer, Darker, Thicker and Beautiful eyelashes in a matter of weeks
Q: What is SUSAR and how to submit that?
A: SUSAR is Serious and Unexpected Suspected Adverse Reaction. The sponsor must report in an IND (Investigational New Drug) safety report any suspected adverse reaction to study treatment that is both serious and unexpected. Before submitting an IND safety report, the sponsor needs to ensure that the event meets all three of the definitions such as
- Suspected adverse reaction
- Serious
- Unexpected
If the adverse event does not meet all three of the definitions, it should not be submitted as an IND safety report.
Readers Note: A specially designed weight loss programs is combined with an exciting new breakthrough ingredient that comes with a complete online comprehensive diet and weight loss programs to help you lose weight. Here are Garcinia UltraPure, New Tonic Supplement, Viva Slim liquid drops, 30 Days to weight loss program to burn fat while eating foods you love using home workouts
Q: What CFR Guideline references from FDA for MAH?
A: The Regulations from FDA as below
| Regulation Product | Regulation Product |
| 21 CFR 310.305 | Prescription drugs marketed for human use without an approved application |
| 21 CFR 314.80 | Human drugs with approved NDAs. Post-marketing reporting of ADE. |
| 21 CFR 314.98 | Human drugs with approved ANDAs. Post-marketing reports. |
| 21 CFR 600.80 | Human biological products with approved BLAs |
| 21 CFR 600.81 | Human biological products with approved BLAs |
| 21 CFR 314.81(b)(2) | Annual reports |
| 21 CFR 314.90 | New drug applications: Waivers |
| 21 CFR 314.540 | Accelerated approval of new drugs for serious of lifethreatening illnesses: Post-marketing safety reporting |
| 21 CFR 314.630 | Approval of new drugs when human efficacy studies are not ethical or feasible: Post-marketing safety reporting |
| 21 CFR Part 4, Subpart B | Post-marketing safety reporting for combination products. |
Readers Note: A complete protein diet. Pure liquid egg whites are the purest form of protein known to man in the entire world and are 100% bio-available
Q: What is seriousness criteria? What scenarios to be considered as serious?
A: Seriousness criteria as follows:
- Death
- Life-threatening adverse experience
- Initial inpatient hospitalization or prolongation of hospitalization
- Significant or persistent disability/incapacity.
- Congenital anomaly/birth defect (including that occurring in a foetus).
- Important medical event based upon appropriate medical judgment that may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the other outcomes listed in the definition of serious
An emergency room visit that results in admission to the hospital would also qualify for the initial inpatient hospitalization outcome. However, emergency room visits that do not result in admission to the hospital would not qualify.
Readers Note: A unique 2-step process releases free oxygen to oxidize and lift organic stains away from teeth. Let us begin this patented dental whitening system, Teeth Whitening 4 You to remove stains with only one use
Q: How MAH need to deal with psychotropic drugs?
A: Persons incarcerated because of actions allegedly caused by a drug (e.g., psychotropic drugs and rage reactions) have sustained a substantial disruption in their ability to conduct normal life functions. Thus, these adverse experiences would qualify for the significant or persistent disability/incapacity outcome.
Q: Can MAH record patient name in any report?
A: No. MAH should not record the name of patient anywhere. Patients should not be identified by name or address. Instead, the applicant should assign a unique code (e.g., patient initials) to each report.
Readers Note: Find a revolutionary scientific breakthrough for controlling unsightly cellulite and eliminating inches with Dermology Cellulite Cream
Q: If MAH could not submit the serious unexpected (Expedited) case to FDA within 15 day timeline, then, when can MAH submit that report?
A: If the 15th calendar day occurs on a weekend or U.S. Federal holiday, the 15-day report should be submitted the first working day after the weekend or U.S. Federal holiday.
Q: What is STN in PADER as per FDA?
A: Submission tracking number (STN).
Readers Note: You wanna try this 12-week Yoga Burn Challenge. Really effective
Q: How MAH need to deal with Literature reports?
A: Serious, unexpected adverse experiences reported in the scientific literature that are known to the applicant must be submitted as 15-day reports. Reports of serious, unexpected adverse experiences described in the scientific literature should be submitted for products that have the same active moiety as a product marketed in the United States. This is true even if the excipient, dosage forms, strengths, routes of administration, and indications vary.
When a serious, unexpected adverse experience is based on a foreign language article or manuscript, the applicant should translate the publication into English promptly. The original article or unpublished scientific paper and translation should be attached.
Readers Note: Do you find any of natural herbal colon cleansing treatment that has changed hundreds of thousands of people’s lives? Yes, here is a through and effective internal cleansing with Bowtrol
Q: Is it required for MAH to submit foreign reports as per FDA?
A: Yes. Reports of foreign serious, unexpected adverse experiences should be submitted for products that have the same active moiety as a product marketed in the United States. This is true even if the excipient, dosage forms, strengths, routes of administration, and indications vary.
Q: How MAH deal with lack of efficacy cases?
A: All spontaneously reported cases of a lack of effect that occur in the United States should be reported on FDA Form 3500A and submitted in the periodic report.
Readers Note: Discover how women are using this 30 second Thyroid Technique to switch on their fat burning hormone and see a flat and firm belly in only 21 Days without starving, long workouts
Q: How MAH need to deal with internet reports?
A: Adverse experience information that is submitted to an applicant via the Internet (e.g., e-mail) should be reported to the FDA if the applicant has knowledge of the four basic elements for an individual case safety report.
Applicants should review any Internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any Internet sites that are not sponsored by them.
However, if an applicant becomes aware of an adverse experience on an Internet site that it does not sponsor, the applicant should review the adverse experience and determine if it should be reported to the FDA.
Readers Note: Vertigo and dizziness are the leaches in many lives which disturbs their routine work. These easy head balance exercises will treat all types of vertigo and dizziness. Start today
Q: How MAH need to deal with Prescription Drugs Marketed for Human Use without an Approved Application?
A: For prescription drugs marketed for human use without an approved NDA or ANDA, all serious, unexpected adverse experiences must be reported to the FDA within 15 calendar days. Post-marketing periodic reports should not be submitted for these drugs.
Q: How MAH deal with Adverse experiences of Unapproved indications?
A: An adverse experience associated with the use of a product for an unapproved indication should be reported to the FDA as is required for any other spontaneously reported adverse experience occurring in the United States (e.g., 15-day report for a serious, unexpected adverse experience or periodic report for a non-serious, unexpected adverse experience). However, a lack of effect report for an unapproved indication should not be reported on an FDA Form 3500A. Instead, such information should be included in the narrative summary section of a periodic report.
Readers Note: Natural Bladder Control Program for people with renal problems. Flotrol is a Natural Bladder Support supplement
Q: How MAH deal with reports from FDA?
A: Sometimes FDA forwards individual case safety reports to applicants. For example, applicants can participate in the FDA’s MedWatch-to-Manufacturer Program. This program is designed to expedite transmission from the FDA to applicants. Details of the program can be found on the Internet at www.fda.gov/medwatch/report/mmp.htm. Applicants that receive individual case safety reports from FDA are not required to resubmit them to the Agency. However, follow-up information to these initial reports must be submitted to the FDA.
Q: How MAH deal with Product defects?
A: If a product defect results in an adverse experience, the adverse experience should be reported as any other spontaneously reported adverse experience occurring in the United States (e.g., 15-day report for a serious, unexpected adverse experience or periodic report for a non-serious, unexpected adverse experience).
Readers note: Parkinson’s disease is a worst disorder in many lives. Let us give a concrete wall of ourselves from this dreadful disease with 12 simple steps tackled the initial phase itself
Q: How MAH need to deal with coding of Adverse experiences?
A: Companies currently use a variety of medical terminologies to code adverse experiences in individual case safety reports (e.g., COSTART, WHOART, MedDRA). However, as recommended by ICH, the Agency encourages companies to use MedDRA for this purpose.
Q: How MAH deal with MedDRA to get License?
A: Companies can license MedDRA from an international maintenance and support services organization (MSSO) (toll free number 877-258-8280 (703-345-7799 in Washington D.C. area), fax 703-345-7755, e-mail subscrib@meddramsso.com, Internet at www.meddramsso.com).
Readers Note: Thousands of people are now suffering from Gout and wants to control those problems. Even though, there were many products in market, why people still searching to get free? Now I’m in
Q: Where FDA Form 3500A is available to download?
A: From the Internet at www.fda.gov/medwatch/report/mfg.htm. Print the form or download it as a PDF file. Form software can also be downloaded and used to complete the forms using a personal computer.
Q: What formats MAH can use to submit the adverse reactions?
A: Applicants can use an FDA Form 3500A or, if preferred, a CIOMS I form for submission of 15-day reports of foreign adverse experiences to the FDA. Applicants cannot use a CIOMS I form for submissions of adverse experiences that occur within the United States. For these adverse experiences, an FDA Form 3500A must be used.
Readers Note: Are you suffering from Bad Breath. Avoid Bad Breath effectively forever with this program
Q: Is it necessary to submit the reports to FDA even the drug is not marketed?
A: Yes. It is mandatory. Once a drug is approved, applicant holders MUST receive, evaluate, and report all adverse drug experiences (ADEs) to FDA, even if the drug is not marketed.
Q: What to submit as Expedited reports?
A: NDA, ANDA, BLA, and unapproved prescription drugs: Submit within 15 calendar days of information receipt.
- Spontaneous: serious, unexpected ADEs.
- Solicited: serious, unexpected, possibly related ADEs
OTC Monograph products: Submit serious, domestic ADEs within 15 business days of information receipt.
Readers Note: Try this Tonsil Stones Remedy Forever
Q: What are Non-expedited (Periodic ICSRs) reports?
A: NDA, ANDA, BLA: Submit with periodic safety report
- Spontaneous: serious, expected ADEs
- Spontaneous: non-serious ADEs
- Not applicable for literature, study, or foreign ADEs
- Not applicable for unapproved prescription and OTC monograph products
Q: What is NDA?
A: New Drug Applications (NDA)
Readers Note: For pregnant ladies who does not have suffice lactation, the best product to boost the milk production
Q: What is ANDA?
A: Abbreviated New Drug Applications (ANDA).
Q: What is BLA?
A: Biologic License Applications (BLA).
Readers Note: you want to get out of Diabetic and its affiliated complications? Let us do it by sticking to the Diabetes Freedom program, by using the Genuine Blood Sugar Solution
Q: What is OTC?
A: Over-the counter (OTC).
Q: What are solicited sources of Adverse experiences?
A: Please find the below.
- IND Studies
- Some patient support programs
- Patient registries
- Post marketing requirements/Commitments
- Epidemiology or surveillance studies
- Phase IV Studies
Readers Note: Let us get a trail version for the renal problems with the Kidney Disease Solution
Q: What are spontaneous sources of Adverse Experiences?
A: Please find the below
- Scientific Literature
- Foreign and Domestic experience.
- Commercial Marketing
- Speciality pharmacies
- Sales force
- Business partners
Q: What is FAERS Public dash board?
A: https://fis.fda.gov/sense/app/777e9f4d-0cf8-448e-8068- f564c31baa25/sheet/7a47a261-d58b-4203-a8aa-6d3021737452/state/analysis
It has more than 14 million reports since 1969. Over 1.81 million new reports in 2017
Readers Note: Age factor is main culprit for Back Pain. Let us override this with this Breakthrough
Q: What is DILIN?
A: Drug-Induced Liver Injury Network (DILIN)
Q: Which format of Aggregate reports FDA accepts?
A: FDA accepts all three formats, the PADER/PAER, PSUR, and PBRER, to fulfil the post-marketing periodic safety reporting requirements under 314.80(c)(2) and 600.80(c)(2). Each format must be submitted according to the content and timelines specified in the regulations.
Q: What is guidance for PADER from ICH?
A: In November 1996, the ICH endorsed the ICH E2C Periodic Safety Update Report Guideline (ICH E2C(R1). FDA adopted that guideline and, in May 1997, published it as FDA guidance for industry Periodic Safety Update Reports for Marketed Drugs
Readers Note: Controlling of high Blood Pressure. Is it possible? Yes it is possible with this easy and simple style
Q: What are the FDA guidelines for PSUR Waivers?
A: FDA has granted waivers under 314.90(b) and 600.90(b) (21 CFR 314.90(b) and 600.90(b)) to allow applicants to substitute the PSUR.