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To correct one of the most common problems that sidetracks ANDA submissions, the FDA recommends bioequivalence studies for most drugs submitted as ANDAs should use a two-period, two-sequence, single-dose, crossover study design. Read More
Beginning today, new safety and efficacy findings that emerge during postmarket clinical trials should be reported in periodic safety update reports (PSURs) submitted to the European Medicines Agency (EMA). Read More
Clinical investigators in India must begin video recording the informed consent process for each study subject, the latest step in the government’s initiative to clean up the country’s troubled clinical trial industry. Read More
Generics makers should design tablets and capsules to be similar in size and shape to their reference listed drug (RLD) when they seek ANDA approval, the FDA says. Read More
An agreement is expected to be reached on the Clinical Trial Regulation between EU lawmakers and the European Council by Christmas, and industry groups are asking to ensure the timelines for submissions are predictable and no longer than those already established in the current directive. Read More
The CMS Tuesday clarified a top concern of drugmakers: which format to use for submitting reports required under the Physician Payment Sunshine Act. Read More
In an effort to head off one of the most common problems that sidetracks ANDA submissions, the FDA is telling drugmakers that bioequivalence studies for most drugs submitted as ANDAs should use a two-period, two-sequence, single-dose, crossover study design. Read More
Devicemakers seeking regulatory approval in the U.S. are strongly urged to blind patients and investigators in pivotal clinical trials, when possible, according to final guidance issued by the Food and Drug Administration. Read More
Medtech sponsors should balance the need to demonstrate safety and efficacy with the potential risks to patients when determining the size and duration of a clinical trial, a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency says. Read More
In the latest effort to clean up India’s troubled clinical trial industry, the government is requiring that clinical investigators video record the informed consent process with each study subject. Read More