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March 2016 will likely be known for a myriad of actions taken by the US government to deal with drug overdose caused by prescription painkillers. First CDC released a new guideline for doctors who prescribe painkillers, followed by two new guidance documents by FDA, one adding a new black-box warning on all opioid painkillers, and … Read more

The breakthrough therapy designation (BTD) has been lauded as one of the most innovative of regulatory pathways as it modifies the conventional drug development, review and approval processes to speed up availability of new drugs to the patients. Since its implementation in 2012, more than 100 drugs have obtained this designation and already 39 new drugs have … Read more

FDA and CDC took several major steps this month to address abuse of prescription opiates. Opiate abuse is a major healthcare issue and has been termed a “crisis” and an “epidemic”. A detailed action plan was announced by FDA last month, one of the first major actions by the new FDA Commissioner.  Abuse or Overdose accounts for about … Read more

Since the 2013 DOJ ruling against the Indian generic manufacturer, Ranbaxy, Indian manufacturers have been constantly in the news for all the wrong reasons. Although India is home to one of the World’s largest generic drug and API manufacturing industry with about 700 FDA-approved manufacturing facilities, the general impression is that Indian regulations are lax, and … Read more

The cardinal rule of raw material vendor management is to verify that vendor’s specification and documents related to the raw material being sourced. Errors in the quality of raw material could compromise the quality of the final product. In pharmaceutical GMP, raw material risk management is one of the core competencies. Not so in other … Read more

Social media holds a great promise as a recruitment tool for clinical trials. One can argue that sponsors can create awareness for a given trial and get more potential subjects contact sites by using social media. The most common social media portal used in clinical trial recruitment is Facebook, followed by clinicaltrials.gov and advertisement on patient specific web-sites. … Read more

The Breakthrough Therapy designation is perhaps one the strongest incentives available to developers of innovative therapies in the US. Since implementation of the Breakthrough designation in 2012, FDA has designated about 110 products and approved 30 new products in this category. Now European Medicines Agency (EMA) has created its own version similar to the US regulatory pathway, called … Read more

Medical researchers in Cuba invented a vaccine, called CimaVax-EGF, for lung cancer. CimaVax has been tested in about 7 well-designed clinical trials in patients with advanced non-small-cell lung cancer (NSCLC), and used to treat about 5000 patients over the last 2 decades. This one of a kind vaccine costs about $1 per shot and patients need to take one shot every month. … Read more

A recent GAO report on the public support for the Priority Review Voucher (PRV) program presents a mixed picture where the industry loves the program and wants it to be maintained while the FDA has an exactly opposite opinion. PRVs have been around for about 7 years since the first PRV program was implemented in 2007 with great fanfare. … Read more

A survey conducted by the Government Accountability Office (GAO) found that FDA does not have robust processes to oversee the safety of drugs approved under expedited programs. There are 4 programs under which new drugs can be approved by FDA under reduce testing burden and shorter review times. These programs are priority review, breakthrough therapy designation, accelerated … Read more