FDA has expanded its patent certification list to include additional data that can help subsequent generic drug applicants determine when their products can be approved and marketed, the agency announced Tuesday (June 18).
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Rx Drugs
June 18, 2019 |
Daily News
American Hospital Association Executive Vice President Tom Nickels said the group plans to make information from 1,100 hospitals on how they use the 340B drug discount program public and to share information from AHA’s voluntary transparency initiative with the Health Resources and Services Administration.
June 18, 2019 |
Daily News
Senate health committee Chair Lamar Alexander (R-TN) told Sen. Robert Casey (D-PA) and the rest of the health committee he is committed to finding a path forward for over-the-counter drug monograph reform legislation that has stalled in the Senate.
June 18, 2019 |
Daily News
Some biologics experts are perplexed by the Trump administration’s argument that subjecting biologics products to United States Pharmacopeia (USP) monographs would hamper innovation.
June 18, 2019 |
Daily News
Americans for Safe Access and data company Aurelius Data Inc. have partnered to develop a research platform that will compile use, perception and biometric data on consumers who are using cannabis products to help their medical conditions, and will make those insights available in a subscription-based database that allows users to see what regimens patients are using.
June 18, 2019 |
Daily News
Senate health committee Chair Lamar Alexander (R-TN) said Tuesday (June 18) that his committee will mark up its bipartisan legislation to lower health costs next week.
June 17, 2019 |
Daily News
The Pharmaceutical Research and Manufacturers of America is running attack ads that say AARP cares more about insurers than seniors, but AARP says the poll that PhRMA is relying on for that message is so misleading that the seniors’ group filed a complaint with the organization that guards against push polling.
June 17, 2019 |
Daily News
Former FDA Commissioner Scott Gottlieb named payer tactics as one of the biggest obstacles facing the gene therapy space, as novel drugs seeking coverage after receiving FDA approval are often viewed by payers as not having enough data on which to base a coverage decision.
June 14, 2019 |
Daily News
Amgen, Merck and Eli Lilly on Friday (June 14) filed a lawsuit to block the Trump administration from forcing drug makers to disclose drug prices in advertisements.
June 14, 2019 |
Daily News
Former FDA Commissioner Scott Gottlieb defended drug maker Pfizer’s choice to not investigate signals that its anti-inflammatory drug Enbrel appeared to reduce the risk of Alzheimer’s, as the Washington Post reported on June 4.
June 14, 2019 |
Daily News
Congressional Medicaid advisers on Friday (June 14) released their June report recommending statutory changes intended to reduce government spending on prescription drugs in Medicaid, give states more time to cover new drugs, and tighten the definition of the so-called Medicaid shortfall.
June 14, 2019 |
Daily News
CMS will allow Washington to enter outcomes-based contracts with drug makers in Medicaid under a State Plan Amendment that facilitates use of a subscription model for purchasing hepatitis C drugs, the agency announced Wednesday (June 12).
June 13, 2019 |
Daily News
Drug pricing is the top priority for House liberals for the next two to four weeks as they try to pull policies to the left before Speaker Nancy Pelosi (D-CA) brings legislation to the floor, Reps. Pramila Jayapal (D-WA) and Mark Pocan (D-WI) said Wednesday (June 12).
June 13, 2019 |
Daily News
The United States Pharmacopeia, backed by generic drug makers and multiple pharmacist groups, has launched a full-scale effort to quash a proposal by the Senate health committee and Trump administration to remove biologics from USP monograph standards, arguing the proposal would reduce confidence in biosimilars.
June 13, 2019 |
Daily News
A device industry lawyer said FDA’s software precertification test plan could help FDA win the statutory authority it needs to implement the pre-cert program, as it could give lawmakers the evidence they need to conclude the program achieves the same level of safety validation as FDA’s traditional review pathways.
June 13, 2019 |
Daily News
FDA’s decision to center its compounding regulatory program in the drug center’s compliance office represents a shift to a more enforcement-focused approach to compounding, according to a drug compounding lawyer.
June 13, 2019 |
Daily News
FDA on Wednesday (June 12) issued a call for stakeholders to send pathogen samples to the agency in order to help build a database to support the rapid identification of infectious diseases in patients.
June 13, 2019 |
Daily News
As part of their investigation into the dangers of illicit fentanyl, much of which comes from China, a bipartisan group of House Energy & Commerce Committee leaders wrote to FDA Acting Commissioner Ned Sharpless and heads of five other federal agencies to request briefings on the effect the opioid epidemic is having on public health and on their solutions for stopping the flow of illicit fentanyl into the United States.
June 11, 2019 |
Daily News
Florida GOP Gov. Ron DeSantis on Tuesday (June 11) signed the state legislature’s bill that orders Florida to create a Canadian prescription drug importation program. Florida is the third state to pass such a law, and the first to enact one law passed by a Republican-dominated legislature.
June 11, 2019 |
Daily News
White House budget officials began reviewing Tuesday (June 11) HHS’ final version of a rule to ban drug rebates in Medicare and Medicaid that aren’t shared at the point of sale.
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