The contents of the Approved Product Dossier do not change in the new AMCP Format for Formulary Dossiers, but there is so much to talk about with this type of dossier, so we will be covering it section by section in the coming weeks.

Section 3 may be the second-longest section in any dossier, as it is based on the level of evidence available for a product at the time the dossier is created or updated. Section 3 contains the clinical evidence, which is displayed through study summaries and evidence tables.

AMCP Format v4.1 Posts_AMCP_Approved_Section 3

Follow our page to keep up with all of the sections of the new AMCP Format for Formulary Submissions. If you need any assistance with creating or updating your dossier, let us know: 877-477-0977 or https://medcommunications.com/contact-us/

#AMCP #dossierwriting #managedcare

The contents of the Approved Product Dossier do not change in the new AMCP Format for Formulary Dossiers, but there is so much to talk about with this type of dossier, so we will be covering it section by section in the coming weeks.

Section 2 is one (or the) longest section in any dossier, so this week’s PDF is very long. Section 2 includes the product description, comparison to other similar products, the place of the product in therapy, disease description, approaches to treatment, and information about accompanying companion diagnostic test (CDTs, if relevant).

AMCP Format v4.1 Posts_AMCP_Approved_Section 2

Follow our page to keep up with all of the sections of the new AMCP Format for Formulary Submissions. If you need any assistance with creating or updating your dossier, let us know: 877-477-0977 or https://medcommunications.com/contact-us/

#AMCP #dossierwriting #managedcare

The contents of the Approved Product Dossier do not change in the new AMCP Format for Formulary Dossiers; it’s more about the fact that it has a new name to differentiate it from the Unapproved Product and Unapproved Use Dossiers. But there is so much to talk about with this type of dossier, so we will be covering it section by section in the coming weeks.

In Section 1, the information provided is almost identical to the previous version of the Format for Formulary Dossier (v4.1). Its purpose is that of any executive summary, summarize what’s in the larger document for someone not deeply involved who needs to know at a high level why to choose this product over another to treat a certain population with a certain disease.

AMCP Format v4.1 Posts_AMCP_Approved_Section 1

Follow our page to keep up with all of the sections of the new AMCP Format for Formulary Submissions. If you need any assistance with creating or updating your dossier, let us know: 877-477-0977 or https://medcommunications.com/contact-us/

#AMCP #dossierwriting #managedcare

In an Unapproved Product Dossier, the information in some of the sections is different than what’s included in those sections in an Approved Product Dossier. Because the product is not approved by the US Food and Drug Administration yet, these dossiers should NOT provide value propositions or conclusions/characterizations about safety and effectiveness. Without the same level of data on a product, this type of dossier is much shorter.

AMCP Format v4.1 Posts_AMCP_Unapproved_Sections

Check back for more information on changes in the new AMCP Format for Formulary Submissions. If you need any assistance with creating or updating your dossier, let us know: 877-477-0977 or https://medcommunications.com/contact-us/

#AMCP #dossierwriting #managedcare

The new European Union (EU) Medical Devices Regulation (MDR), which was supposed to become fully active on May 26th, 2020, has been postponed for 1 year, in light of the COVID-19 crisis.

The MDR, which replaces the existing Directive 93/42/EEC(MDD), will introduce important modifications affecting all aspects of the supply chain and life cycle for medical devices, aiming to increase harmonization across the region, addressing weaknesses in the current regimes, and increasing protection for consumers.

While this additional year gives the medical device industry some time to prioritize their response to COVID-19-related challenges, they should also diligently continue their effort to prepare the implementation of rules in accordance with general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures, and clinical investigations in order to respond to the obligations set forth in the MDR.

This coming year will obviously be very busy and the medical device manufacturers will likely face the same challenges in 2021 as they do today in terms of clinical data collection as part of their Post-Market Surveillance (PMS), only in an even more difficult regulatory environment.

This delay is an opportunity for medical device manufacturers to rethink their MDR strategy and ensure that they are “MDR ready” in spite of the COVID-19 pandemic.

Med Communications is ready to assist your company in understanding the regulation and aligning your business to be in compliance with the expected changes. Contact Stacy Witham to set up a call with members of our Pharmacovigilance team.

#pharmacovigilance #EUMDR #medicaldevices

In the Special Content Considerations section of the AMCP Format for Formulary Dossiers, the last topic is Heterogeneity of Treatment Effect. Health care decision makers need to know how certain treatments are likely to affect their patient populations, so information on the heterogeneity of treatment effect can make a difference in their decision making. The AMCP Format encourages manufacturers to provide available information on different sub-populations and their responses to treatment in their dossiers.

Check back for more information on changes in the new AMCP Format for Formulary Submissions. If you need any assistance with creating or updating your dossier, let us know: 877-477-0977 or https://medcommunications.com/contact-us/

#AMCP #dossierwriting #managedcare

It’s not easy to have a fully remote company, as many companies are realizing. You have to have good systems, great managers, and excellent employees. Med Communications has had a remote workforce for over 10 years, with over 60% of employees working virtually. We have robust internet and phone systems, which are backed up regularly and a detailed plan for disaster recovery, so our clients never experience any disruption in service.

If you need a partner who can take care of your call center, pharmacovigilance, or medical writing, and who has a workforce experienced in working remotely, please contact us: 877-477-0977 or https://medcommunications.com/contact-us/

#remoteworking

Like many in-person conferences this spring, the DIA MASC conference was moved to a virtual format, and it will now take place May 5-7. While the Medical Communications Primer―which included sessions by our Director of Med Communication, Ellen Whipple―took place on March 22, the rest of the conference will be available both live and on-demand over the rest of this week. Ellen also participated in an on-demand session called A Whole New World: Real World Evidence (RWE) with Donna Booth, which will be available at any time to those who have registered.

You can still register and see the schedule here: https://www.diaglobal.org/conference-listing/meetings/2020/03/medical-affairs-and-scientific-communications-forum/virtual

If you can’t make it to DIA MASC and need virtual training in medical information, medical communication, or medical affairs for your team, please contact us: 877-477-0977 or https://medcommunications.com/contact-us/

#DIAMASC #MedComm #medicalaffairs

In recent years, we have witnessed an increase in patients’ expectations for more innovative approaches from pharmaceutical companies in developing medical products that are easy to use, deliver the correct dose of a drug to a precise part of the body, and do so according to a set schedule.

Combination products (medical products combining devices, drugs, and/or biologics) play an important part in meeting these patient expectations, but patient safety remains paramount in this changing environment. Application holders for combination products must understand their responsibilities and work to meet safety requirements from the US Food and Drug Administration (FDA).

The FDA released its final guidance for industry and FDA staff on July 22, 2019, to further clarify how application holders can comply with the 2016 Postmarketing Safety Reporting requirements (PMSR) for combination products, as codified in 21 CFR Part 4, Subpart B.

By July 2020, it is expected that combination products application holders using the FDA Adverse Event Reporting System (FAERS) and Electronic Medical Device Reporting System (eMDR) will comply with the Final Rule on PMSR.

By the end of January 2021, the Vaccine Adverse Event Reporting System (VAERS) will be ready to receive individual case safety reports (ICSRs) according to Final Rule on PMSR.

Is your company ready to meet these requirements for your combination products? Are you sure?

Our pharmacovigilance team can provide full-service pharmacovigilance to ensure your company meets the FDA requirements. If you have questions or need more information, contact us: 877-477-0977 or https://medcommunications.com/contact-us/

#PMSR #combinationproducts #FDA

In the Special Content Considerations section of the AMCP Format for Formulary Dossiers, the fourth topic is Biosimilars. With the interest in biosimilars, health care decision makers need to know if there is data to prove that biosimilars are as effective as their innovator/reference drug. The AMCP Format encourages biosimilars to create dossiers that provide the same level of evidence data as innovator/reference drugs and which delineate between direct and extrapolated evidence.

AMCP Format v4.1 Posts_Biosimilars

Check back for more information on changes in the new AMCP Format for Formulary Submissions. If you need any assistance with your dossier (or other documents) for a biosimilar product, let us know: 877-477-0977 or https://medcommunications.com/contact-us/