The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Tuesday released a report summarizing its research activities in fiscal year 2022 in 13 different scientific areas under the Generic Drug User Fee Amendments (GDUFA III).   The research generated from the program enabled FDA to issue 177 new and revised product-specific guidances (PSGs), 59 of which were for complex products, according to the summary.   “The recommendations in many of th...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. to end COVID-19 emergency declarations on May 11 ( Reuters ) ( Bloomberg ) ( STAT ) As COVID Public Health Emergency Winds Down, US FDA Employs Flexibility For Rx EUA Transitions ( Pink Sheet ) FDA Launches Plans for Food Program Revamp After Watchdog Review ( Bloomberg ) End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timefr...

The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors develop acromegaly treatments for patients who have either not responded to surgery or are in poor health.   Acromegaly is a chronic, rare disease in adults caused by excess growth hormone that can cause enlarged hands and feet, among other symptoms. The most common cause stems from a growth hormone that stimulates hepatic overproduction of insulin-like growth factor-1 (IGF-1).  ...

Many pharmaceutical companies in the EU are waiting on the sidelines to submit new clinical trial applications to the Clinical Trial Information System (CTIS) portal. Companies are either waiting for their colleagues to submit first or are waiting for last-minute technical glitches to be ironed out first, said an expert who recently spoke to Regulatory Focus on CTIS implementation.   Other experts told Focus that while the requirement to submit all new trials to CT...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves another indication for Keytruda, this time in the adjuvant NSCLC setting ( Endpoints ) ( FDA ) ( MedPage Today ) Lilly Gets U.S. FDA Approval of Jaypirca to Treat MCL ( Bloomberg ) ( BioSpace ) ( Endpoints ) FDA approves Italy-based pharma's oral SERD for some breast cancer patients ( Endpoints ) ( Fierce ) Drugmakers prevail in dispute over U.S. ...

The US Food and Drug Administration (FDA) on Thursday released a roadmap on its science and research priorities for fiscal years 2023-2027 to spur the development of biosimilars and interchangeable products.   Under the Biosimilar User Fee Amendments (BsuFA) III program, FDA has offered $5 million in funding for several research proposals under the regulatory science pilot program (RELATED: FDA offers funding for biosimilar regulatory science pilot , Regulatory Foc...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA joins global regulators probing tainted overseas cough syrup ( Reuters ) ( CBS News ) AstraZeneca’s Covid Drug No Longer Authorized for Use in the US ( Bloomberg ) ( STAT ) Live blog: Tracking the meeting of the FDA advisory panel on Covid vaccines ( STAT ) Inhibikase, FDA find common ground to lift hold on Parkinson’s drug ( Fierce ) Updated COVID v...

The International Council for Harmonisation (ICH) has adopted a revised version of its Q9 guideline that aims to improve current quality risk management (QRM) programs by creating more objective risk assessments, which could potentially reduce quality defects as well as drug shortages.   The ICH Q9(R1) guideline was published on 20 January, and updates the original guideline, which is now 18 years old. It covers the principles of QRM, the general QRM process, risk mana...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Many pediatric drug study results were never posted to a U.S. government database ( STAT ) COVID Vaccines: What FDA Isn’t Talking About Ahead Of Upcoming Advisory Panel ( Pink Sheet ) US FDA Wants Global COVID-19 Vaccine Update System, But Says May Not Be Possible ( Pink Sheet ) Advisory Committee Disagreement With US FDA On Approval Decisions An Increasingly Rar...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA scientists propose an annual Covid shot matched to current strains ( STAT ) ( Reuters ) With TheracosBio green light, another SGLT2 wades into diabetes arena ( Fierce ) Cidara’s Rezafungin: US FDA Panel Asked To Weigh ‘Limited Use’ Indication For Antifungal ( Pink Sheet ) FDA One Step Closer To Makena Withdrawal After Hearing Officer Echoes Advisory Panel’...

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, Ranking Member of the House Energy & Commerce Committee Frank Pallone (D-NJ) wrote to FDA Commissioner Robert Califf and Lawrence Tabak, acting director of the National Institutes of Health (NIH), urging greater enforcement of clinical trial results reporting in ClinicalTria...

The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or rating a manufacturers quality management maturity (QMM) program. These were some of the lessons learned as the agency develops a future rating program for evaluating manufacturers on drug quality, according to results reported in a 10 January article published in The AAPS Journal .   These pilots “afforded FDA the opp...