By THOMAS M BURTON The House on Wednesday passed a bill to let the Food and Drug Administration collect about $6 billion in user fees from medical companies to help fund the agency. The bill, passed in a bipartisan majority voice vote, is expected to reach a final vote in the Senate next week. The…
SUMMARY OF FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT TITLE I – FEES RELATED TO DRUGS Under this section, the drug industry would pay over $700 million in FY 2013 and higher amounts in the remaining four years. In exchange, FDA would commit to the following: (1) meeting performance goals regarding the timely review…
By DEBRA SHERMAN The number of Americans living with cancer will increase by nearly a third to almost 18 million by 2022, according to a report released on Thursday by the American Cancer Society and the National Cancer Institute. Researchers found that even though the incidence rates of cancer are decreasing, the number of cancer…
By STEPHANIE BEASLEY The National Institutes of Health announced the addition of five drug companies to a new program that would pair the companies with researchers in order to repurpose pharmaceutical compounds that advanced to clinical studies but were not approved for their original indication. On Tuesday (June 5) NIH said Abbott, Bristol-Myers Squib Company,…
By STEPHANIE BEASLEY A top FDA drug center official refuted the idea that the number of oncology drugs going through accelerated approval is on the decline, as industry and patient groups have recently asserted. Deputy drug center director Bob Temple said the agency has not become more reluctant to accept historical control trials and the…
By ALAINA BUSCH A recently introduced bipartisan Senate bill proposing a breakthrough drug designation to expedite development for drugs that show promise early on could work in tandem with another pending proposal targeting accelerated approval process, according to stakeholders backing both proposals, which are eyed as policies to be attached to FDA user fees. FDA…
By NELLIE BRISTOL Screening rates for three prominent cancers were lower among Asians and Hispanics in 2010, indicating a continuing trend of racial and ethnic disparity. But the testing gap for African American women has closed for some services, according to a study released Thursday by the Centers for Disease Control and Prevention. Among Asians,…
By NANCI BOMPEY This year’s appropriations process could be more difficult for FDA than it has been in recent years because of a more constrained budget environment, the unlikelihood that major initiatives — like the food safety law — will continue to enjoy funding hikes, new funding needs that could surface through the reauthorization of…
By NANCI BOMPEY This year’s appropriations process could be more difficult for FDA than it has been in recent years because of a more constrained budget environment, the unlikelihood that major initiatives — like the food safety law — will continue to enjoy funding hikes, new funding needs that could surface through the reauthorization of…
By NANCI BOMPEY This year’s appropriations process could be more difficult for FDA than it has been in recent years because of a more constrained budget environment, the unlikelihood that major initiatives — like the food safety law — will continue to enjoy funding hikes, new funding needs that could surface through the reauthorization of…
