On February 9, FDA announced approval of a new drug to treat Duchenne muscular dystrophy. In fact, NDAs 208684 and 20685 (oral tablets 6, 18, 30, and 36 mg and oral suspension 22.75 mg/mL), both orphan drugs, were approved that day. However, by February 13, Reuters reported that “Marathon pauses Duchenne drug launch amid price outcry”.…
DetailsAs pharmaceutical consultants, the scientists and regulatory professionals at PDG® design pharmacokinetic (PK) protocols for a wide variety of applications. This paper has been written to provide the reader with a basic review of pharmacokinetic and pharmacodynamics (PD) principles as well as an exposure to a cross section of the utility of PK studies. Click…
DetailsScienceDaily reports on a new study from the European Society of Cardiology: “Statin side effects are the strongest predictor of failure to meet low-density lipoprotein (LDL) cholesterol targets, according to research published today in the European Journal of Preventive Cardiology. Other predictors were statin non-adherence and use of weaker statins…Patients with side effects were more than…
DetailsWorld Pharma News reports that “Scientists at Winship Cancer Institute of Emory University have mapped a vast spider web of interactions between proteins in lung cancer cells, as part of an effort to reach what was considered “undruggable.” This approach revealed new ways to target cells carrying mutations in cancer-causing genes. As an example, researchers…
DetailsGPhA announced at the 2017 Annual Meeting that they are adopting a new name. Now known as Association for Accessible Medications (AAM), PDG extends its sincere thanks to their staff and fellow participants for making the meeting a good one. We congratulate our $100 Visa gift-card winner, and particularly enjoyed the keynote speaker, Captain “Sully” Sullenberger. …
DetailsAccording to FDA’s What’s New Related to Drugs, on February 16, CDER published Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017. Here’s a link to the document and here is a link to contact us with your drug development concerns.
Industry Can Notify FDA Drug Shortage Staff via CDER Direct NextGen “The Food and Drug Administration released a new technology platform for Industry to send drug shortage and supply notifications. CDER Direct NextGen allows Industry users to login, enter their shortage information, and submit to the FDA.” Upgraded Drug Shortages app for Android devices…
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As pharmaceutical consultants, the scientists and regulatory professionals at PDG® design pharmacokinetic (PK) protocols for a wide variety of applications. This paper has been written to provide the reader with a basic review of pharmacokinetic and pharmacodynamics (PD) principles as well as an exposure to a cross section of the utility of PK studies. While…
DetailsOn January 25, 2017, FDA introduced an important new data update to the Orange Book . Search results and drug listings will now “clarify which listed drugs are reference listed drugs (RLDs) and which are reference standards. Listings also indicate which products in the Discontinued Section may be referred to as an RLD. The FDA…
DetailsAccording to FDAnews Drug Daily Bulletin “FDA said it would not wait for the Federal Register to publish determinations that a reference listed drug’s removal from sale had nothing to do with safety and effectiveness. Previously, the FDA would publish its findings that a drug was removed from the market for reasons other than its…
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