Many of today’s most important medications are biologics. Among the notable conditions treated by biologics are rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions and various forms of cancer. As you probably perceive, biosimilars are to biologics what generics are to brand-name drugs. However, there are major differences between the…
“President Donald Trump’s administration released its budget blueprint for FY 2018 on Thursday, March 16, calling for a hike in user fees from industry to make up for cuts elsewhere at the US Food and Drug Administration (FDA)…While the blueprint offers little detail on what such cuts would actually mean for the agency and pharmaceutical,…
We doubt it. However, after 6 years, FDA may be on the verge of finalizing the “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” rule. We called it the “Generic CBE rule” until 2014 when PhRMA and GPhA got together and proposed an alternative known as the Expedited Agency Review. That would…
FDA Voice reports that “Last year, FDA’s Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research generated the highest number of approvals in the history of FDA’s generic drug program – more than 800 generic drug approvals, including both full approvals and tentative approvals. (Tentative approvals are granted to applications ready…
Citing the University of Sydney, and the Journal Nature, ScienceDaily reports that, “The warning follows a speech to Congress last week by President Trump in which he said the US Food and Drug Administration’s drug approval process was ‘too slow and burdensome,’ and where he promised to ‘slash the restraints, not just at FDA but…
FDAnews Drug Daily Bulletin reports that “After almost three years of negotiations, the U.S. and the European Union have agreed to recognize each other’s drug GMP inspections. The new pact amends the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement, to avoid duplication and cut costs for inspections”. Click here for the full but…
Many of today’s most important medications are biologics. Among the notable conditions treated by biologics are rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions and various forms of cancer. As you probably perceive, biosimilars are to biologics what generic drugs are to brand-name drugs. However, there are major differences between…
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”.…
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. Click…
ScienceDaily 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…