Toxicological Insights for the Global Pharmaceutical Industry
BLOG
FDA – Standards, Publications, Regulations and Laws, Recalls, and Safety News (Four CD-ROM Set)
Now available, a comprehensive superset of 4 CD‑ROMs which provide an up-to-date collection of documents, manuals, publications, and reference sources on the FDA, including drug safety.
Can the FDA Go Public with Proprietary Information?
The FDA proposes publishing drug/device rejection letters, including any safety concerns that led to the decision.
Orphan Drug Development: Midsize to Large Company Perspectives
Blockbusters can get their start in rare diseases. Orphan indication exclusivity can be one aspect of a profitable drug’s overall product life cycle, including non-orphan uses, and can contribute to its profitability.
FDA Encourages Applications for Orphan-Drug Status
The FDA is offering intensive workshops to give on-the-spot regulatory advice to companies ready to file orphan drug applications by the end of the 2-day period. European meetings may be forthcoming.
ICH Guidance “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals” issued
The guidance provides recommendations for preclinical studies for the development of pharmaceuticals, including both drugs
and biotechnology derived products, intended to treat patients with advanced cancer. The recommendations describe the type and timing of preclinical studies to support an investigational
new drug application (IND) and the submission of a new drug application (NDA) or biologics license application (BLA).
New MHRA pharmaceutical directory resource
The UK Health Agency (MHRA) now has a one-stop page for the pharmaceutical industry to access information.
Strengthening the business of personalized medicine
Pharmacy benefit managers (PBM) may be tweaking the business model for personalized medicine, thereby enhancing drug safety. PBMs anticipate to make money by selling personalized medical services to employers, who are willing to pay them higher fees for improved health outcomes and lower prescription costs.
Drug Pharmacokinetic Comparison between Humans and Monkeys
For 8 of 13 drugs, the results suggest that first-pass intestinal metabolism is greater in cynomolgus monkeys than in humans, and that bioavailability in cynomolgus monkeys after oral administration may be unsuitable for predicting pharmacokinetics in humans.
Preclinical Safety Evaluation: moving from risk identification to risk reduction
Revolutionizing the way that toxicology is applied, such as moving from a hazard identification and risk assessment preclinical paradigm to one that reduces or eliminates risk prior to major expenditures, may provide a means of narrowing the productivity gap within the biopharmaceutical industry. This paper provides an overview of safety issues for initial exploration and cites possible techniques available to address them in the preclinical space.
New Regulatory and Enforcement Emphasis of FDA on Drug Safety
James N. Czaban (FDA Practice Group, Wiley Rein LLP) discusses trending topics of the FDA in regard to drug safety.
Contact TigerTox to learn more:
Copyright 2015-2023, TigerTox, All rights Reserved