Aspects of Regulatory History in the US

The beginnings of all that the USFDA regulates can be traced right to the early decades of the founding of the nation. In a sense, the FDA, even if came to be called by that formal name much later; embodies the discipline and value set that the new created nation sought to represent. Regulation of […]

Good Documentation Practice Guideline is simple: just write

Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent. Good Documentation Practices are essential for […]

FDA Warning Letters – an understanding

As the primary regulator of the biological, healthcare, life sciences and other related industries; the FDA has power and authority over how its work is carried out. FDA Warning Letters are among the primary mediums through which it enforces its authority. The FDA issues a Warning Letter to a company when it determines, following its […]

Tougher FDA import rules are aimed at putting strict controls on imports

Import rules are very rigid and strict in the US, because products of any type and variety can enter the US. The US being the world’s largest consumer economy; manufacturers and marketers from around the world vie for a chunk of this market. The FDA, being the agency that regulates a myriad of products, has […]

FDA Requirements for ensuring Premarketing Clinical Trial Safety

The FDA has set out requirements for sponsors and organizations that carry out clinical trial to ensure premarketing clinical trial safety. This is a very vital requirement because this is the stage at which the database that goes into clinical trials is formed. Its integrity and safety is an important ingredient for assessing the risks […]

The FDA’s requirements for non-IND Foreign Clinical Studies

The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical products that are permitted under this system of foreign clinical studies include: A human drug A biological drug A medical device […]

The Investigational New Drug Applications mechanism in the USA

The IND is a process which gives the sponsor the opportunity to start marketing across the States of the US without having to complete the formal process. it also gives the patient the assurance that the drug that is being administered may not have gone through the full regulatory process as yet, but is as […]

What is logistics and supply chain management?

Logistics and supply chain management (SCM) constitute a very important element of businesses. Getting the logistics and supply chain management aspects right is necessary for the smooth flow of products from their source to destination, during the course of which many activities need to be performed. Logistics and supply chain management is emerging as a […]

The FDA’s Adverse Event Reporting Requirements

The adverse event reporting system is an important highlight of the FDA’s adverse event reporting requirements. This is the mechanism through which adverse event reporting requirements are listed out for the FDA to take further action. The adverse event reporting system may be understood as being a database that aids and supplements the FDA’s postmarketing […]

Philadelphia woman tries passing fake scripts at Palmer pharmacy

PALMER TWP., Pa. – A Philadelphia woman is facing fraud charges after she allegedly arrived at a Northampton County pharmacy Wednesday night with fake prescriptions for more than 200 pills. Police arrested Samantha M. Brown at a Palmer Township Rite Aid with fraudulent prescriptions for Oxycodone, Alprazolam and Flexiril. The 25-year-old now faces three felony […]