Knowledge Base - Massachusetts Biotechnology Council - Massachusetts Biotechnology Council

Hogan Lovells: Life Sciences and Health Care Horizons 2019 Hogan Lovells March 22, 2019

In the 2019 edition of our Life Sciences and Health Care Horizons publication, our global team identifies a number of current and evolving trends that are shaping the future of the industry. Read More

Annex 13 June 5, 2018 in White Papers,

This guide walks US-based clinical supply professionals through the EU GMP Annex 13 labeling requirements. Read More

Outlook for OTC Drug Regulation Hogan Lovells May 2, 2018 in White Papers,

Through a combination of new legislation, regulations, and enforcement policies, a new regulatory framework is coming for OTC drugs. Read More

Conducting Feasibility for a New Clinical Trial April 10, 2018 in White Papers,

What does the word “feasibility” mean to you? It may seem like a simple question, but I have found that “feasibility” has many interpretations within the clinical research industry. When we work with Read More

Clinical Endpoints: What Do Payers and Regulators Want? April 5, 2018 in White Papers,

The requirement that new drugs show effectiveness is based on a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. This law requires substantial evidence of effectiveness and specifies that t Read More

Not Just Tiny Humans: Considerations for Conducting Pediatric Clinical Trials April 3, 2018 in White Papers,

When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. While we can’t predict the outcome, pla Read More

Implementing Patient-Centric Principles in Asthma Research March 28, 2018 in White Papers,

The term patient centricity is fraught with uncertainty for many. This term carries the nuances of widely varying practical application methods as well as theoretical disagreements from stakeholders Read More

Life Sciences and Health Care Horizons 2018 Hogan Lovells March 28, 2018 in White Papers,

Our global Life Sciences and Health Care team reports on current and evolving trends that are shaping the future of the industry. Read More

Many U.S. Clinical Trial Sponsors Are Unprepared for New EU GDPR Regulation February 8, 2018 in Advisories,

Policy

As of May 2018, U.S. sponsors of clinical studies conducted in the EU must be in compliance with EU's new General Data Protection Regulation or risk possibility of fines. Read More

Common Rule Implementation Delayed for Six Months January 17, 2018 in Advisories,

The Department of Health and Human Services has proposed a one-year delay in implementation of the revisions to the Common Rule. Read More