Pharmaceutical Industry News Roundup: July 2019

by Staff writer

Each month, MMS shares key stories on the evolution of the pharmaceutical industry. Here is a selection of top stories to keep an eye on:

Score: Data-sharing practices improve after public ranking—Outsourcing Pharma

The Good Pharma Scorecard — organized by Bioethics International — revealed that large pharmaceutical companies are sharing more clinical trial results data. The Good Pharma Scorecard provides a “harmonized set of measures” that benchmarks sponsors’ data transparency practices.

Maggie Lynch has the full story here

Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry U.S. Food and Drug Administration (FDA)

The FDA recently published industry guidance on how they define types of changes to approved risk and mitigation strategies (REMS), submitting changes to an approved REMS, and how the agency will process submissions. This guidance provides information, as described in section 505-1(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Download the full guidance document via the FDA website

Instructions for Use—Patients Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format Guidance for IndustryU.S. Food & Drug Administration (FDA)

Recently published guidance by the FDA provides recommendations for developing the content and format of an Instructions for Use (IFU) document for certain products or devices as part of a new drug application (NDA) or a biologics license application (BLA). The FDA’s recommendations are meant to help develop consistent content and format across all IFUs to make information clear to patients.

Access the full FDA guidance here

Role of Real-World Evidence in Clinical Trials Needs Definition, Industry and FDA Agree—CenterWatch

Industry leaders and the FDA both highlight the need for a clearer definition of “real world evidence.” Despite draft guidance issued by the FDA in May, the definitions appear vague and commenters noted that the guidance did not solve any problems.

Brandon May and James Miessler have the story here

Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using eCTD Specifications Guidance for IndustryU.S Food and Drug Administration

The FDA is seeking comments by September 16, 2019, regarding its recent guidance on providing regulatory submissions in electronic format. Specifically, the guidance details how sponsors and applicants must organize the content that they submit to the agency electronically.

Visit the FDA website to read the full guidance document

Transforming Regulatory OperationsRAPS.org

Eckart W. Schwarz, MD and Adrian Cottrell of GlaxoSmithKline (GSK) detail how their global pharmaceutical company improved efficiencies by reorganizing the company’s regulatory strategies. By modernizing regulatory systems to support new models, the company was able to transform its operations.

Read the full article via Regulatory Focus

Researchers’ company launches drug development softwareUniversity of Maryland Baltimore

Pumas-AI, a new company established by the University of Maryland School of Pharmacy faculty members released its first software program for pharmaceutical researchers. The software was developed through a partnership with Julia Computing. The software is designed to meet the needs of analysts in the pharmaceutical industry and advance therapeutic innovation in the clinic setting.

Malissa Carroll from the University of Maryland Baltimore has the story

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