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FDA has established a new Rare Disease Innovation Hub (the Hub) to leverage cross-agency expertise and spur the development of treatments for rare diseases, CDER Director Patrizia Cavazzoni and CBER Director Peter Marks announced recently. Read More
The Mark Cuban Cost Plus Drug Company is offering a low-cost, imported penicillin product after being given temporary approval by the FDA to help ease the ongoing shortage of Pfizer’s Bicillin L-A, a long-acting penicillin formulation used to treat syphilis and other bacterial infections. Read More
This week, the FDA published final guidance on drugs for treatment of partial onset seizures, combination product user fees, radiolabeled mass balance study clinical pharmacology considerations. Draft guidance was issued on pediatric inflammatory bowel disease. The agency also announced interactive site tours of biotechnology manufacturing facilities developing cellular and gene therapies. Read More
Sterile drugmakers seeking to comply with new EU GMP guidelines introduced in August 2023 should consider an in-depth gap assessment in their facilities — working through the guidelines line by line, two EU regulatory experts advised. Read More
The FDA has sent an additional warning letter to China-based Jiangsu Shenli Medical Production for quality system violations for its enteral syringe products and expanded the company’s import alert to prevent their enteral syringes from entering the US. Read More
In this edition, we note the release of the EU’s highly anticipated AI Act, new reporting requirements for expected interruptions in the supply of medical devices or diagnostics and new guidance on IVD classifications. Read More
The UK’s Prescription Medicines Code of Practice Authority (PMCPA) has dinged Novartis, Pfizer, Otsuka and Novo Nordisk for breaches of its code of practice. Read More
Orexo announced that it has received a complete response letter (CRL) from the FDA regarding its NDA for OX124, a high-dose naloxone rescue medication for opioid overdose. Read More
Baxter International has issued an urgent medical device recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly as there is a risk of the device becoming disconnected, resulting in loss of ventilation. Read More
The FDA has issued new recommendations on pediatric drug trials, issuing a draft guidance on inflammatory bowel disease (IBD) drug development and a final guidance on extrapolating partial onset seizure (POS) drug efficacy from adults to patients one month and up. Read More
Congressman Jack Bergman (R-Mich.) joined bipartisan lawmakers, veterans and post-traumatic stress disorder (PTSD) experts to highlight the need for FDA approval of midomafetamine (MDMA) -assisted therapy to address the treatment of PTSD and veteran suicide. Read More
The FDA has opted to terminate CBER’s Allergenic Products Advisory Committee due to the expert group’s relative inactivity over the past few years, shifting its duties over to the Vaccines and Related Biological Products Advisory Committee (VRBPAC). Read More