FDA Drafts Guidance on Restricted Delivery Systems for Liquid Drugs

USA – FDA Finalizes Guidance on 503B Bulks List

Today, the US Food and Drug Administration (FDA) issued a final guidance for the drug compounding industry on the 503B Bulks List, which is...
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

USA – FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19...

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including...

USA – FDA offers guidance on generic drug development during COVID

The US Food and Drug Administration (FDA) on Monday released a new questions and answers guidance for generic drugmakers addressing generic product development and...
New guidance on biologics affects authorized generics

USA – FDA issues clinical pharmacology draft guidance for antibody-drug conjugates

The US Food and Drug Administration (FDA) on Monday issued a draft guidance on clinical pharmacology considerations for sponsors interested in developing antibody-drug conjugates (ADC). There...
Evaluating Reproductive Toxicity in Oncology Drugs: FDA Finalizes Guidance

USA – Complex Generic Drugs: FDA Offers Two Draft Guidances

The US Food and Drug Administration (FDA) on Tuesday unveiled one revised draft guidance and another new draft guidance to help advance the development...
EU Court of Justice Rules in Favor of EMA in Transparency Case

USA – Drugmakers Sue HHS for Trying to Add Prices to DTC Ads

Amgen, Merck, Eli Lilly and the Association of National Advertisers on Friday sued the Department of Health and Human Services (HHS) because of a...

USA – Guidance : Development and Licensure of Vaccines to Prevent COVID-19

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic...
NICE rejects Janssen’s Stelara on cost efficiency grounds

USA – Positive Phase III results for Valneva’s chikungunya vaccine

The trial, involving 4,115 adults, aged 18 years and above, across 44 sites in the US, met its primary endpoint of inducing protective CHIKV...

USA – FDA finalizes guidance on drug bioavailability studies

The US Food and Drug Administration (FDA) has published a final guidance on the bioavailability (BA) data drug sponsors should include in their premarket...
FDA Encourages Inclusion of Older Patients in Cancer Trials

USA – FDA Issues Draft Guidance on NASH Drug Development

The US Food and Drug Administration (FDA) on Monday issued draft guidance on developing drugs to treat patients who have noncirrhotic nonalcoholic steatohepatitis (NASH)...

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