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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 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
The FDA has issued new recommendations on pediatric drug trials, issuing a draft guidance on inflammatory bowel disease (IBD) drug development and a final guidance on extrapolating partial onset seizure (POS) drug efficacy from adults to patients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
The FDA has issued final guidance on application fees for combination products, explaining that when a sponsor submits a single application for a combination product, the fee should be for that application. Read More
This edition of Quick Notes focuses on congressional urging for approval of MDMA for PTSD and FDA approvals for J&J’s tuberculosis treatment Sirturo, a biosimilar for Eylea, a Stelara biosimilar and accelerated approval for Epkinly. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
The FDA has called out three drugmakers for lack of compliance with current good manufacturing practices (cGMP) and marketing unapproved products, among other lapses. Read More
A Texas pharmaceutical marketer was sentenced to two years and five months in federal prison and ordered to pay over $59 million in restitution for conspiring to defraud the US, receiving illegal kickbacks in exchange for compounded medications prescription referrals, and money laundering. Read More
This week, the FDA published a final guidance on clinical considerations for studies of opioid use devices. Draft guidances were issued for misinformation about drugs and devices, use-related risk analyses and 510(k) submissions for dental composite resins and dental curing lights. Read More