Clinical Research Solutions
Critical Components of Quality Management Systems
Critical Components of Quality Management Systems: In 1962, Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP), which must be compliant...
Clinical Research Solutions
Solar Eclipse 2017: Taking a Look Back
As we’re sure already you know, last week North Americans experienced a total solar eclipse. Leading up to the big event, thousands of articles and blog posts were written about the historical event...
Clinical Research Solutions
FDA Aims to Reduce Tobacco-Related Disease & Death with New Plan for Tobacco & Nicotine Regulation
On Friday, July 28, 2017, the FDA released a new, comprehensive plan concerning the regulation of tobacco and nicotine. This multi-year regulatory plan is part of the Agency’s attempt to protect...
Clinical Research Solutions
FDA Issues Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies, Requests Comments
On Tuesday, July 11th, FDA released its draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies for the electronic submission of this...
Clinical Research Solutions
FDA Approves 1st Drug for Sickle Cell Disease in Nearly 20 Years
On Friday, July 7th, the FDA approved Endari (L-glutamine oral powder) to reduce the complications associated with sickle cell disease in patients age five years and older. What is Sickle Cell...
Clinical Research Solutions
Sterility Concerns Cause Voluntary Recall of Various Products: Potassium Phosphate & Succinylchoine Chloride
On June 15, 2017, Hospira Inc. issued a voluntary recall of a number of its products after finding a microbial growth during a routine simulation of the manufacturing process, which represents the...
Clinical Research Solutions
FDA to Host Public Workshop to Discuss the Impact of Abuse Deterrent Opioids
On Wednesday, June 14th, the FDA announced plans to host a public workshop regarding the impact of opioid formulations with abuse deterrent properties. The workshop, entitled “Data and Methods for...
Clinical Research Solutions
US Opioid Epidemic: FDA Requests the Removal of Opioid from the Market
On Thursday, June 8th, the FDA requested that Endo Pharmaceuticals remove Opana® ER (oxymorphone hydrochloride), an opioid pain medication, from the market. History with FDA The FDA originally...
Clinical Research Solutions
FDA Warns OTC Manufacturer After Finding Inaccurate Information in Product Listings
On Thursday, June 1st, the FDA issued a Warning Letter to Prestige Brands Holdings, an over-the-counter (OTC) drug manufacturer. PediaCare Children’s Plus Multi-Symptom Cold and PediaCare Children’s...
Clinical Research Solutions
FDA Makes Changes to Regulations Concerning Humanitarian Use Devices
On Wednesday, June 7th, the FDA amended its final rule concerning humanitarian use devices (HUDs). The amendments to the regulations are being made in response to changes recently enacted into law by...