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A new draft Guidance Document on “Gifts to FDA” could be one of the strangest documents of its kind released by the Agency in its history. The document defines a “gift” to the FDA and then details the various rules that would govern the evaluation and acceptance of such gifts. Only the FDA Commissioner is … Read more

Last month, FDA held a public hearing to collect public opinions about enacting a new user fee for over-the-counter (OTC) drugs. The presenters at the hearing could be divided into three groups with distinct preferences. The FDA was the host of the hearing and a strong proponent of the OTC user fee giving several reasons why a user fee … Read more

In his State of the Union address this year, President Obama announced the “Cancer Moonshot” of the US government whereby multiple aggressive initiatives were launched to find cures for cancer. Over the last six months, numerous initiatives have been announced to encourage research, increase patient participation in clinical trials, and expedite the approval of new cancer drugs. … Read more

It has been a week since UK voted to leave the European Union. There have been rampant speculations on what this decision means for the drug industry. Dooms day scenarios painted by a several commentators would have us believe that most work by regulators in UK and the EU would be negatively affected. But a careful review of the … Read more

Last week a report made a sensational claim that even cheap meals influence which prescriptions are written by doctors. The survey of prescriptions written after meals were provided found that there was an increased rate of prescribing the brand-name medication that was being promoted. Under the Sunshine Act, any payments made by drug companies to individual physicians of … Read more

Last week FDA launched a new campaign to encourage minorities in the US to participate in clinical trials using video clips of a minority participant of clinical trials. FDA declared 2016 as “The year of Clinical Trial Diversity”; this is one of several initiatives launched this year. However, it seems these measures will have little practical effect … Read more

Last month, NIH announced the final policy for IRB review of multi-site clinical trials funded by NIH. Starting next May, all multi-site clinical trials funded by NIH must use a single IRB for all sites. This creates a new paradigm for IRB review of clinical trials aimed to reduce the redundancy and cost of IRB review. The goal … Read more

In a recent survey published in JAMA, patients overwhelmingly preferred their doctors to be dressed in white coat and tie over scrubs or business suits. Only 2% of the patients preferred their doctors to be dressed casually in T-shirts and jeans. Early on in a patient-doctor interaction, the patient forms an opinion about the knowledge and … Read more

The news of questionable science and data integrity issues at Theranos has filled prime time news for several months. Critics have variously chastised the company for all aspects of its operations. However, the blame for this does not rest only on Theranos; the industry as a whole made major mistakes in not checking one of its own. But there … Read more

FDA and EMA have been increasingly harmonizing regulatory requirements in Europe and US for most drug and biological products for the last two decades and it seems soon they may get even closer. This week European Medicines Agency (EMA) released a report disclosing ongoing discussions with FDA to set up ground rules for simultaneous review and approval of drugs, … Read more