All Food and Drug Administration (FDA) articles
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Industry newsFDA programme set to improve diversity in clinical trials
The US FDA’s Oncology Center of Excellence has launched an initiative to improve access to clinical trials for under-represented populations.
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InterviewDr Peter Marks on reflecting innovation through FDA regulation
Harriet Edwards and Dr Katherine Bowen spoke to Dr Peter Marks, Director of Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA), about his career and the continued evolvement of regulation to support innovative medicines development
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Industry newsUtah law to permit non-FDA-approved stem cell therapies
Utah has passed legislation that will allow patients to receive placental stem cell therapies without the need for FDA approval.
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JournalClinical trial design – keeping up with innovation
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Abstract A well-designed clinical trial is essential for the collection of reliable, robust and meaningful data to ensure the protection of participants rights and safety and also minimise economic losses ...
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CommentaryCell and gene therapy rare disease drug development in the US – general principles, challenges and a landscape of mutual regulatory concession
Cell and gene therapy rare disease drug development in the US – general principles, challenges and a landscape of mutual regulatory concession
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Industry newsDevice which can detect skin cancer approved by FDA
The FDA has approved a wireless hand-held device that uses an artificial intelligence-powered algorithm to detect skin cancer.
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JournalThe changing face of oncology development – is cancer still ‘different’? A US perspective
Oncology development has traditionally been thought of as ‘different’; that the rules that applied to other therapy areas were not necessarily applicable to the development of treatments for cancer patients, who until relatively recently, had exceedingly limited treatment options. Dose finding was based on the paradigm adopted for cytotoxics and ...
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Industry newsNon-hormonal menopause drug approved in UK
The MHRA has authorised a non-hormonal medicine, Veoza, which targets a protein in the brain to stop vasomotor symptoms in menopause.
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Industry newsCyber risk standard gets FDA backing for medical devices
The FDA has encouraged the use of a consensus standard to help device manufacturers address growing concerns over cyber security in devices.
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Industry newsFDA to establish Digital Health Advisory Committee
The FDA has established a Digital Health Advisory Committee to help the agency explore issues related to digital health technologies (DHTs).
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Industry newsFDA committee finds OTC decongestants to be ‘ineffective’
An FDA committee has reviewed phenylephrine − the active ingrediant in many over the counter decongestants − and agreed it is ineffective.
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JournalWarning letters for direct-to-consumer advertising: a five-year retrospective analysis
Background: Direct-to-consumer pharmaceutical advertising (DTCPA) is a ‘grey area’ that the Food and Drugs Administration (FDA) in the United States (US) regulates through the Centre for Drug Evaluation and Research (CDER). One of the purposes of DTCPA is to educate and empower patients via popular media such as television, radio, ...
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JournalA critical review and comparison of the processes when seeking Scientific Advice in the EU and the USA – Part 2
GRAY, MSc − PART TWO OF A TWO-PART SERIES(See part 1 here) Scientific Advice (SA) is provided by all major regulatory agencies to pharmaceutical companies and other interested parties who are developing new medicines. Regulatory agencies such as EMA and FDA regard provision of SA as a ...
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Industry newsFDA's Emerging Technology Programme
The FDA’s Emerging Technology Programme intends to assist industry in gaining regulatory approval for innovative technology drug applications.
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Industry newsFDA approves its first nonprescription birth control pill
FDA approves first over-the-counter (OTC) contraceptive pill for use in the US − it is expected to become the most effective OTC birth control.
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JournalG-E-T-ting there – how gene editing technologies could change more than genes
The field of genome editing technologies (GETs) is rapidly advancing, marking a new and exciting era of curative medicines. These products can alter genetic material in patients, highlighting the crucial need to introduce dedicated legislation to ensure that GETs are developed and maintained in a safe and effective manner.
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Industry newsFirst anaemia drug for cats given ‘expanded conditional approval’
Varenzin-CA1 is the first drug approved for cats with nonregenerative
anaemia, under the FDA’s expanded conditional approval pathway. -
Industry newsFDA approves world’s first RSV vaccine for use in over 60s
A first vaccine, developed by GSK, for respiratory syncytial virus has been approved by the FDA for use in adults aged 60 years and older.
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JournalCMC considerations for US biosimilars development
The US Biologics Price Competition and Innovation Act of 2009 (BPCI Act) provides an abbreviated licensure pathway for biosimilar products. This pathway brought the hope of lower cost biologics, perhaps similar to what was accomplished by generics for small molecule drugs. Twelve years have now passed since the BPCI Act and experience continues to be gained with biosimilars development…