FDA
Modernization of Cosmetics Regulation Act (MoCRA)
March 9, 2023
MoCRA 2022: Updated Requirements for Cosmetic Companies
MoCRA enacts the most significant expansion of the US FDA to regulate cosmetics since 1938. After 85 years of effectiveness the Modernization of Cosmetics Regulation Act of 2022 or "MoCRA" was...
FDA
Rare Diseases
March 1, 2023
Challenges in Clinical Development of Products for Rare Disease
Rare diseases are defined in the Orphan Drug Act as diseases or conditions that affect less than 200,000 people in the United States. There are over 7,000 rare diseases affecting more than 30 million...
Rare Diseases
Orphan Drug Act
February 28, 2023
Rare/Orphan Diseases and the African American Community
How do we improve outcomes for an uncommon healthcare challenge in a community challenged with common healthcare issues? The Orphan Drug Act defines a rare disease as a disease or condition that...
ATMP
February 20, 2023
The Boston ATMP Biotech Conquest
After panning over the Boston Business Journal and seeing yet another local VC (Venture Capital) firm raise a record $350 million in venture capital for Massachusetts life science, I asked myself:...
Life Science Consulting
December 6, 2022
Changes to the Animal Welfare Act Affecting Animal Research Facilities
Does your organization conduct or outsource testing to an Animal Research Facility? If so, are you aware of the changes that have been implemented to the AWA (Animal Welfare Act) by the Animal and...
Regulatory Sciences
November 2, 2022
Ban on Titanium Dioxide (E171) on the EU Food Market: What Are the Consequences for Medicines?
Use of Titanium Dioxide in the EU Food Market In 2021, the European Food Safety Authority (EFSA) investigated the safety of the white coloring agent titanium dioxide (TiO2) and concluded that the...
Life Science Consulting
November 1, 2022
Be Careful What You Ask For (Prior to Consent)
According to FDA’s clinical trial regulations (21 CFR 50.20, 312.60 and 812.100), clinical investigators are responsible for protecting the rights, safety, and welfare of subjects during a clinical...
Life Science Consulting
October 28, 2022
ProPharma Group's Dr David Crome to Act as Compliance Monitor to the MHRA
From April 2022, the MHRA has been developing a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM) on behalf of companies that have...
Life Science Consulting
October 26, 2022
Your Vendor Audit Program: On-site or Remote / Virtual?
It is quite common that a sponsor company will outsource services to external vendors, whether for additional expertise, remote locations, or simply due to lack of availability of resources within...