Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This was a big news week for FDA watchers – we saw the release of the Biden administration’s FY 2024 budget request and FDA’s roadmap for how it will handle dozens of COVID-19 pandemic era guidances now that the COVID-19 public health emergency (PHE) is winding down.   In a Federal...

The European Medicines Agency (EMA) this week issued a question-and-answer guidance to address sponsors’ questions on its pilot testing the review of raw clinical trial data for marketing authorization applications (MAAs) and post-authorization applications.   EMA issued an updated guidance on the pilot in October. (RELATED: EMA to explore reviewing raw data from clinical trials in applications , Regulatory Focus 12 July 2022)   The purpose of the pilot is to ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US Baby Food, Formula Safety Get FDA Focus in Biden Budget Request ( Bloomberg ) US FDA flags shortage of medication used to treat breathing conditions ( Reuters ) ( Fierce ) Where are all the generic inhalers for asthma and COPD? Researchers call for patent and FDA reforms ( Endpoints ) U.S. FDA approves Amphastar Pharma’s nasal spray for opioid overdose ( Reuters ) ...

Pharmaceutical manufacturers in the EU may have to approach the manufacturing of sterile drugs a little differently under the EU’s Annex 1 covering good manufacturing practices (GMPs), which goes into effect soon. For example, regulators may be asking to see whether firms have a documented contamination control strategy (CCS) and may require firms to conduct pre- and post-sterilization integrity testing (PUPSIT) on filters used in sterile drug manufacturing.   In the m...

Sterile drug manufacturing is a high-risk operation and to manage these risks, drug manufacturers need to “tightly control” a multitude of variables to ensure processes remain in a state of control, asserted Brooke Higgins, a senior policy advisor for global compliance in the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).   Higgins outlined some of the consequences that can occur when these variables are not controlled, includin...

Updated 7 March 2023 to clarify what products FDA's guidance on potency assays for monoclonal antibodies applies to.   Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we learned that the agency is indeed moving forward with rulemaking to get diagnostics reform, a top official involved in the Aduhelm approval story is ...

A proposed reorganization of the Food and Drug Administration Office of Regulatory Affairs (ORA) will “modify things significantly” for foods as well as medical products and is expected to be finalized this fall, said Janet Woodcock, the agency’s principal deputy commissioner at a 2 March webinar sponsored by the Alliance for a Stronger FDA.   Woodcock offered an update, yet few specifics, on the proposed restructuring of ORA, first floated on 31 January. Key among the...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Two for two: GSK follows Pfizer, secures adcomm thumbs-up for RSV vaccine in older adults ( Endpoints ) ( Bloomberg ) ( Fierce ) ( Pink Sheet ) Pfizer gets FDA panel’s backing in RSV vaccine race ( Reuters ) U.S. regulators rejected Elon Musk’s bid to test brain chips in humans, citing safety risks ( Reuters ) ( Forbes ) Factbox: Neuralink, other brain-chip mak...

The US Food and Drug Administration (FDA) is soliciting feedback on how to incorporate artificial intelligence (AI) and advanced manufacturing techniques into the current regulatory framework for pharmaceutical manufacturing in a new discussion paper.   The paper, which was jointly released by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) on 1 March accompanies the agency’s release of the International Co...

[ Editor's Note: This article has been updated 3 March 2023 to clarify HDA's role in conducting the survey .]  The pharmaceutical industry and its trading partners have made “significant strides” in sharing transaction data with each other, which is a key element in medicine traceability mandated by the Drug Supply Chain Security Act (DSCSA). Yet there are still barriers to exchanging this data, according to a recent survey by the Healthcare Distribution Alliance (HDA...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer, GSK face FDA panel review in race for RSV vaccines ( Reuters ) FDA Grants Orphan Drug Designation to Jaguar Health for Crofelember for Microvillus Inclusion Disease (MVID), a Second Rare Disease Indication in the US ( BioSpace ) FDA Seeks to Further Restrict Unlawful Importation of Xylazine ( Bloomberg ) ( WSJ ) Pandemic-era insider trading scheme nett...

The pharmaceutical industry would like to get more clarity on the timing of drug-drug interaction (DDI) studies and the scope of these DDI studies in their comments to regulators on the proposed International Council for Harmonization’s (ICH) M12 guideline, said a regulator at an ICH regional meeting sponsored by the US Food and Drug Administration (FDA) and Health Canada on 24 February.   Rajanikanth Madabushi, associate director for guidance and scientific policy at ...