Newsletter - April 20, 2017
Should Medical Food Clinical Trials be Conducted Under INDs? May be
Last month, FDA issued a Warning Letter to a California medical foods company, Targeted Medical Pharma (TMP), for conducting clinical trials without an IND. This is an interesting case study that highlights common regulatory issues with most companies doing clinical trials, and more specifically medical food and supplement developers. Read More
What Are the Most Common GMP Deficiencies Found by FDA?
The regulators publish lists of common deficiencies to create awareness about the kind of concerns raised by auditors in a given period. Such lists are useful to understand the common areas of error and may help reduce those findings in future at other organizations. Few weeks back, MHRA, the regulators in the UK, published common findings in GMP audits..Read More
Should Medical Food Clinical Trials be Conducted Under INDs? May be
Last month, FDA issued a Warning Letter to a California medical foods company, Targeted Medical Pharma (TMP), for conducting clinical trials without an IND. This is an interesting case study that highlights common regulatory issues with most companies doing clinical trials, and more specifically medical food and supplement developers. Read More
What Are the Most Common GMP Deficiencies Found by FDA?
The regulators publish lists of common deficiencies to create awareness about the kind of concerns raised by auditors in a given period. Such lists are useful to understand the common areas of error and may help reduce those findings in future at other organizations. Few weeks back, MHRA, the regulators in the UK, published common findings in GMP audits..Read More
