USA – FDA relaxes EUA advertising limitation for some COVID drugs
The US Food and Drug Administration (FDA) has relaxed a limitation on advertising and promotion for certain COVID-19 drugs with emergency use authorizations (EUAs)....
UK – Research provides hope for patients with neurodegenerative disease
Scientists have discovered a new treatment that slows the progression of neurodegenerative disease in mice. The breakthrough research may offer hope in tackling currently...
UK – NICE publishes draft guidance recommending three COVID-19 treatments
The treatments recommended by NICE are Roche’s RoActemra (tocilizumab) and Eli Lilly’s Olumiant (baricitinib), both indicated for use in a hospitalised setting in patients...
USA – FDA Adds/Revises Product-Specific Guidances
The FDA has issued 29 new product-specific draft guidances and 22 revised draft guidances for complex and non-complex generic drug products.
The guidances provide product-specific...
USA – Stakeholders ask FDA to harmonize adverse events terms with standards orgs
Pharmaceutical companies are asking the US Food and Drug Administration (FDA) for more adverse events reporting standardization by harmonizing with standards organizations as well...
International – Modular plug-and-produce facilities for cell therapies
At the start of 2021, a crane lifted a shrink-wrapped, elongated structure off a truck flatbed and through a window into an upper floor...
Europe – Expert: Combination product firms need EU guidance amid regulatory ambiguity
The EU Medical Device Regulation (MDR) created confusion for medical device manufacturers in Europe, including drug-device combination (DDC) producers. As stakeholders seek more guidance...
UK – New T-cell study demonstrates ‘powerful’ potential for tailored cancer medicine
The clinical study involved 16 patients with either colon, breast or lung cancers that had failed to respond to other treatments, and was made...
USA – Industry pushes FDA for tailored complex generics post-approval changes guidance
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...
USA – FDA takes first step to allow low-dose OTC naloxone on market
Low-dose naloxone drug products, including certain nasal sprays and autoinjectors, could one day be sold without a prescription, according to an initial assessment by...