BASEL, Switzerland – In a pandemic-like situation, the European Medicines Agency (EMA) should reserve resource-intensive activities for promising medicines and should reinforce its cooperation with partners such as the EU National Immunization Technical Advisory Groups (NITAGs). That’s according to the agency’s Melanie Carr, who spoke at DIA Europe 2023 on some of the knowledge EMA gleaned from the COVID-19 pandemic.   Carr, head of stakeholders and communications divi...

BASEL, Switzerland – Work is progressing to overcome the obstacles associated with European decentralized clinical trials and advance their adoption, regulatory and industry officials said during a panel session at DIA Europe 2023. An upcoming guideline from the International Council on Harmonisation (ICH) may soon boost these efforts.   At the meeting, a panel of EMA officials, representatives of patient groups, and pharmaceutical industry representatives discussed so...

BASEL, Switzerland – DARWIN EU is starting to collect more real-world data (RWD) and gain more adherents as an increasing number of regulators and industry groups recognize the value of RWD, Peter Arlett, head of the European Medicine Agency’s data analytics and methods task force, said at DIA Europe 2023.   RWD saw a significant boost from the COVID-19 pandemic, Arlett said. Pre-pandemic, when EMA recommended the establishment of the Data Analysis and Real World Inter...

The US Food and Administrations (FDA) on Thursday finalized guidance defining what constitutes suspect and illegitimate products, as well as what constitutes products that are counterfeit, diverted, stolen, fraudulent or unfit for distribution.   The guideline aims to help industry meet their verification obligations under the Drug Supply Chain Security Act (DSCSA) which requires trading partners to be able to identify a suspect or illegitimate product. The guidance ...

Three domestic drug manufacturers were chastised in recent warning letters sent by the US Food and Drug Administration (FDA) for similar good manufacturing practice (GMP) violations related to failure to test incoming components and missing validation programs to ensure products remain in a state of control.   Another problem found at two sites were lax or nonexistent stability testing programs. One company was lambasted for “filthy conditions” at its facility, includi...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US FDA says Pfizer COVID pill EUA for adolescents to stay even after nod for adults ( Reuters ) ( FDA ) Biden says ‘more coming’ on drug pricing after inflation fines ( Reuters ) Abortion-Pill Challenge Hearing Ends Without Judge Ruling ( Bloomberg ) Explainer: How recent lawsuits could affect access to abortion pills ( Reuters ) US FDA Opens OTP Director Search Again...

Pharmaceutical industry stakeholders urged the US Food and Drug Administration (FDA) to better align its investigational new drug application (IND) annual reporting proposal with the International Council’s for Harmonization’s (ICH) E2F guidance on development safety update report (DSUR), especially with regard to the cut-off date for submitting annual reports.   These comments are in response to FDA’s proposed rule issued in December 2022 outlining changes to the ...

The Government Accountability Office (GAO) and the United States Pharmacopeia (USP) asserted in two recent reports that the regulators need to address some of the ambiguities associated with advanced manufacturing to accelerate adoption in the pharmaceutical industry. The GAO further recommended that the US Food and Drug Administration (FDA) should set benchmarks to better measure uptake to this mode of manufacturing.   A USP official discussed both reports, as well as...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US FDA approves first treatment for Rett syndrome, a genetic neurological disease ( STAT ) ( Reuters ) ( Endpoints ) GSK’s $100M ADC net in doubt after fatality in first trial of Mersana’s cancer therapy ( Fierce ) ( Endpoints ) Silicon Valley Bank customers to have all funds accessible, US says, easing biotech and tech turmoil ( Endpoints ) Bristol Myers, Pfizer, AbbV...

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 ) ...