Remove Compounding Remove Dosage Remove Presentation
article thumbnail

Enforcement Trends: CDER Presentation Confirms Fewer Warning Letters Are Issued by FDA for OAI Inspections

FDA Law Blog: Biosimilars

Farquhar — At the GMP by the Sea Conference ongoing in Cambridge, Maryland, a presentation was made by a representative of FDA’s Center for Drug Evaluation and Research that shows some interesting trends in enforcement. By Douglas B. OAI is FDA’s classification for facilities it deems to be in an unacceptable state of compliance.

Dosage 52
article thumbnail

ACMT Toxicology Visual Pearl: Who Doesn’t Like a Nice Rosé?

ALiEM - Pharm Pearls

What clinical presentation and medication is associated with this urinary discoloration?  Deferoxamine binds with ferric iron (Fe3+) to form ferrioxamine, a water-soluble compound excreted in the urine. As Iron toxicity treated with deferoxamine Background Deferoxamine is the treatment for severe iron toxicity [1]. Deferoxamine

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Only 2 per cent medicines undergo quality control checks: Former IMA President

Express Pharma

Presently, over 50% of prescriptions issued by physicians are for fixed dosage combinations spanning various therapeutic categories. Thus, prescribing such medicines using generic names might pose challenges for RMPs, compounded by the difficulty chemists may face in dispensing such prescriptions.

article thumbnail

AMR poses an immediate and widespread threat to global public health: Experts

Express Pharma

Over-the-counter accessibility and limited awareness compound the problem. It is crucial to find a delicate balance in antibiotic dosages, acknowledging that overuse contributes to resistance. Over-the-counter accessibility and limited awareness compound the problem.

Hospitals 101
article thumbnail

Understanding GFI #256: The 4 Takeaways That Matter to Your Veterinary Practice

epicur

The FDA recently finalized regulatory guidance for compounded animal medications from bulk drug substances for use in non-food-producing animals, impacting the way compounded drugs can be used, documented, ordered, and prescribed. Bulk drug substances are the raw active ingredients most compounded medications are made from.

article thumbnail

Researchers from Queen’s University Belfast develop 3D printed bandage to treat diabetic foot ulcers

Express Pharma

Queen’s University Belfast has designed a new 3D printed bandage which presents an innovative method of treatment to heal diabetic foot ulcers (DFUs). Medical professionals also do not need to change the drug dosage as this double release, supports that need.”

article thumbnail

Advanced Biodesign starts first-in-human clinical trial targeting AML

European Pharmaceutical Review

ABD-3001 is the pharmaceutical form of DIMATE, which targets and inhibits a detoxification system present in cancer cells. DIMATE poisons and kills cancer cells, without harming healthy cells. The ODYSSEY study is organised according to an adaptive design.

Dosage 98