USA – FDA issues draft guidance on pulmonary tuberculosis drugs
The US Food and Drug Administration (FDA) has released new draft guidance on developing drugs for pulmonary tuberculosis.
FDA’s latest draft guidance is intended to...
USA – Experts: Give FDA authority to remove ineffective drugs
The FDA is struggling to remove drugs from the marketplace that don’t show effectiveness in late stage trials, new JAMA analyses found, thanks to...
USA – NIH aims to reduce reputation bias in grant reviews
The US National Institutes of Health (NIH) has released a tentative plan to change how its research grant applications are scored, with the aim of reducing...
USA – Industry asks FDA to harmonize pediatric study pharmacology guidance with ICH
Industry groups have asked the US Food and Drug Administration (FDA) to align its recently re-drafted guidance on pediatric clinical pharmacology studies with international...
USA – FDA finalizes PK-based dosing guidance for PD-1/PD-L1 inhibitors
The US Food and Drug Administration (FDA) this week finalized guidance detailing how sponsors of programmed cell death receptor-1 (PD-1) and programmed cell death-ligand...
USA – Using mRNA technology for a universal flu vaccine
Influenza, the virus that causes the flu, can be deadly. Twenty different types of the virus have been identified. Many of these circulate between animals...
USA – Uptake of biosimilars on the rise in the US, but number of...
Fewer biosimilars have been marketed in the United States, compared with Germany and Switzerland, and prices are significantly higher in the US. However, biosimilars...
USA – FDA updates statistical approaches for assessing bioequivalence
The US Food and Drug Administration (FDA) has published a draft guidance updating its principles for assessing in vivo or in vitro bioequivalence studies...
USA – FDA revises ANDA facility correspondence draft guidance
The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking...
USA – Industry groups seek changes to nonprescription drug access proposal
Drugmakers, pharmacists and others are calling for flexibility in the US Food and Drug Administration’s (FDA) proposed rule on requirements for nonprescription drug products...
