Rep. Rosa DeLauro's recent letter to the FDA criticizing expedited approval pathways designed to accelerate the commercialization of innovative treatments does not capture the role of FDA's expedited approval programs in speeding therapies to patients suffering from unmet medical needs and faced with few or no medical alternatives.
FDA Commissioner Margaret Hamburg returned from her trip to India talking up cooperation and collaboration between regulators there and the FDA. Not all regulators there, however, sounded as enthusiastic as she did.
FDA Commissioner Margaret Hamburg returned from her weeklong trip hobnobbing with Indian health regulators and pharma execs with an agreement from health officials there to work more closely with her agency. But India's top drug regulator sounded a little less enthusiastic than others about meeting all of the FDA's high expectations.
Anyone reading the news this week knows what a stray remark from a CEO can do. But pharma executives don't have to mention "distressed babies"--or something equally telegenic--to get themselves in trouble.
FDA Commissioner Margaret Hamburg is in India this week trying to build rapport with regulators and drugmakers in her ongoing quest to stress quality manufacturing in a country that produces a huge amount of the generic drugs used by U.S. consumers. But back home, questions of quality are brewing as Congress prepares to look deeper into whether generic drugs manufactured outside the U.S. are making the grade.
Blood Purification Technologies won FDA clearance to begin human clinical trials of its Wearable Artificial Kidney. Testing will be conducted at several academic medical centers, the company said in a statement. Specific trial dates were not disclosed.
Johnson & Johnson and Pharmacyclics' new drug Imbruvica won the expanded approval it needed to go beyond a rare disease treatment and reach the blockbuster status it was conceived for. The FDA Wednesday gave Imbruvica accelerated approval for treating chronic lymphocytic leukemia in patients who have received at least one previous therapy.
An FDA warning letter told a Hong Kong-based API seller that inspectors found serious quality issues at its distribution facility there and at one in Tempe, AZ. One reason for the lapses, the agency said, appears to be that the ingredient maker has no quality control unit to make sure it meets GMP standards.
F. Michael Ball has spent many earnings calls talking almost entirely about the quality problems at the company's plants and its long-running efforts to get past them. Wednesday he spent very little, an indication, executives said, that four years of effort and more than $375 million in investments are paying off.
A Baxter Healthcare plant in Illinois failed to put in place adequate quality control practices in the manufacture of HomeChoice dialysis and iPump pain management systems, the FDA tells the company in a warning letter.