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 ...

The US Food and Drug Administration (FDA) has issued a final rule intended to ensure patients are better informed about their breast tissue density when undergoing mammography. The rule updates regulations first issued in the 1990s under the Mammography Quality Standards Act to oversee mammography facilities and improve breast cancer testing.   “Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said ...

The US Food and Drug Administration’s (FDA) is seeking to increase its budget authority by 10% in fiscal year 2024 as part of the Biden administration’s $6.9 trillion budget request. While the budget request also includes multiple legislative asks from the agency, it does not address diagnostics reform.   In total, FDA is requesting $7.2 billion in funding, which includes $3.9 billion in appropriated funding and $3.3 billion in user fee funding. Overall, the agency is ...

A group formed to advise the UK government on the regulation of medical devices is pushing for officials to “rapidly explore” building an equivalence route for approvals to include jurisdictions such as the US.   Last year, members of the UK Life Sciences Council, which brings together government, regulators and industry, formed an advisory group to create recommendations on the reform of medtech regulation. With the UK leaving the European Union, the Council saw a “go...

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...

Drugmakers want clarifications on an updated draft guidance the US Food and Drug Administration (FDA) recently released on pre-submission facility correspondence (PFC) for generic drug applications.   In December, FDA revised its draft guidance on submitting PFCs for generic drug applicants seeking a priority review of their abbreviated new drug application (ANDA), prior approval supplement (PAS) or an amendment to either submission type in line with the Generic Drug U...

The European Council (EC) has approved a measure to extend the transition period for medical devices under the Medical Devices Regulation (MDR) and to remove the sell-off provisions for existing products as required under MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR).   On 7 March, the Council voted 27-0 to adopt the measure put forward by the European Parliament and Commission. The parliament voted 537-3 on 16 February to push back the MDR transiti...

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...

The Philippine Food and Drug Administration (FDA) has posted guidelines about relying on the decisions of other regulatory agencies to facilitate the evaluation of clinical trial applications.   FDA, which has moved to increase regulatory reliance in multiple areas in recent years, pitched the new guidance to improve access to investigational drug products for public health emergencies, rare diseases and “emerging and re-emerging infectious diseases of public health th...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US U.S. FDA extends review of BioMarin's bleeding disorder therapy ( Reuters ) California to not do business with Walgreens over abortion pills issue, Governor says ( Reuters ) WeightWatchers Moves Into the Ozempic Market With Telehealth Deal ( WSJ ) ( Reuters ) FDA panel to reevaluate the most common over-the-counter decongestant, phenylephrine, criticized as useless ( C...