The US Food and Drug Administration (FDA) has published a draft guidance updating its principles for assessing in vivo or in vitro bioequivalence studies (BE) for investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and supplements to these applications.   The update replaces a previous version in February 2001 and adds new topics such as assessing the bioequivalence for narrow therapeutic index (NTI) drugs and hig...

A top US Food and Drug Administration (FDA) official touted the benefits of cloud-based regulatory submissions in ensuring consistent product reviews and explained how the agency is moving towards this platform through ongoing internal and international harmonization initiatives at a 30 November symposium on drug master files (DMFs) and structured data submissions.   Lawrence Yu, director of the Office of New Drug Products (ONDP) in the Pharmaceutical Quality (OPQ) at ...

Pharmaceutical manufacturers said the US Food and Drug Administration (FDA) draft guidance specifying quantitative labeling recommendations for sodium, potassium and phosphorus in human over-the-counter (OTC) and prescription drugs conflicts with other existing guidelines and advice from other regulators.   The comments were made in response to the agency’s call for feedback on the draft guidance, released in September 2022, which recommends quantitative labeling of so...

The US Food and Drug Administration (FDA) accepts a wide variety of applications into its Emerging Technologies Program (ETP), and is not just focused on continuous manufacturing, said Joel Welch, associate director for science and biosimilar strategy in the agency’s Office of Biotechnology Products.   “I think that sometimes there is a misperception that advanced manufacturing is just about continuous manufacturing,” said Welch who provided an update on the ETP at the...

The US Food and Drug Administration (FDA) needs to develop guidance on post-approval changes for complex generics, and to update its guidance on post-approval changes for non-complex generics as current versions are outdated, according to representatives of the generics industry.   The remarks were made during a panel on post-approval changes for complex generics on 9 November at the Association for Accessible Medicines’ (AAM) GRx+Biosim held a conference in Bethesda, ...

The complex generic market needs to “achieve parity” with the innovator market, as the number of approvals is lagging the innovator sector and has not achieved its full market potential, said Robert Lionberger, director of the US Food and Drug Administration’s (FDA) Office of Research and Standards in the Office of Generic Drugs (OGD).   Lionberger made the remarks at the Association for Accessible Medicines’ (AAM) GRx+Biosim conference in Bethesda, MD last week.   ...

The US Food and Drug Administration (FDA) blasted Abraxis Biosciences in a recent warning letter for not addressing recurring media fill failures in its aseptic processing operations of the sterile drug Abraxane and for failing to conduct robust follow-up investigations to determine the root cause of these multiple failures.   During a one-week inspection conducted in late March at the firm’s site in Phoenix, AZ, the agency observed “multiple media fill failures” in th...

Lack oversight of contract third parties is a common violation found in warning letters issued by the US Food and Drug Administrations (FDA) to sponsors, who need to exercise proper oversight of those entities that conduct clinical research on their behalf, said several food and drug law attorneys at the Food and Drug Law Institute’s (FDLI) 2 November meeting.   They also recognized that the clinical trial environment is getting more complex, with more non-traditional ...

Joint draft guidance from two centers at the US Food and Drug Administration (FDA) outlines ways sponsors can measure pediatric growth consistently in clinical trials for drugs used to treat both rare and common diseases.   “If an investigational drug or biological product may affect growth or pubertal development, then accurate, serial measurement and recording of growth parameters are essential for data interpretation in pediatric clinical trials,” the agency announc...

Updated 3 November 2022* The discovery of novel nitrosamine impurities in pharmaceuticals, coming after the valsartan/nitrosamine crisis of 2018, has caught global regulators and industry by surprise as more products than anticipated are affected by these impurities.   The situation raises new questions about how to set daily acceptable intake limits for pharmaceutical products when toxicological data on these impurities is scarce.   These novel nitrosamines, ...

The US Food and Drug Administration (FDA) has issued new draft guidance with advice for sponsors on developing drugs for treating Clostridioides difficile infection (CDI).   The draft provides recommendations for designing these trials and covers trial populations, efficacy and safety endpoints, nonclinical studies, and pharmacokinetic studies. The guidance does not address fecal microbiota transplant products.   CDI is an anaerobic, gram-positive, spore-forming ...

Two domestic drug manufacturers were lambasted in recent warning letters sent by the US Food and Drug Administration (FDA) for good manufacturing practice (GMP) violations; one was told to adopt better contamination controls and to keep outsourced drugs separate from those made at the facility, while another was reprimanded for keeping the facility in a poor state of repair.   FDA also targeted two firms for failing to file accurate product information in its electroni...