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Rx Drugs

November 21, 2017 | Daily News

FDA published final guidance on Tuesday (Nov. 21) that lays out how the agency will evaluate generic abuse-deterrent formulations (ADFs) of oral opioids and includes recommendations of the types of studies sponsors should conduct to show the generic ADF is no less abuse-deterrent than its reference listed drug (RLD).

November 21, 2017 | Daily News

The White House is asking Congress to appropriate $7.6 million in additional FDA funding for hurricane recovery, namely to pay for repair of the agency's offices in hurricane-affected areas.

November 21, 2017 | Daily News

Amsterdam was chosen Monday (Nov. 20) as the new seat of the European Medicines Agency in the wake of the United Kingdom's earlier vote to exit the European Union.

November 21, 2017 | Daily News

Patients should be told when co-pays are more than drug cash-prices, according to the American Medical Association.

November 20, 2017 | Daily News

FDA is considering how real-world evidence (RWE) can be used to update product labels, and labeling may be the first area in which the agency develops a clear framework for the use of real-world evidence, agency Commissioner Scott Gottlieb told a group of stakeholders during Friends of Cancer Research's (FOCR's) annual meeting.

November 20, 2017 | Daily News

The White House Council of Economic Advisors (CEA) announced Monday (Nov. 20) that the U.S. government has underestimated the cost of the opioid crisis, and that in 2015 the economic cost was $504 billion, or over six times more than the most recently estimated cost of the epidemic.

November 17, 2017 | Daily News

Half of doctors would lose money each time they administer drugs if Medicare cuts are triggered by Republicans' tax-overhaul legislation, according to those following the tax reform legislation.

November 17, 2017 | Daily News

Generic stakeholders are clashing with FDA over what most thought were completed Generic Drug User Fee Amendments (GDUFA II) negotiations, namely the steps sponsors must take to be eligible for priority review.

November 17, 2017 | Daily News

FDA's recent alert on alleged health risks associated with the herbal product kratom is being challenged by the American Kratom Association, which is petitioning the agency under the Information Quality Act to set up a special advisory committee of independent experts to review the accuracy and integrity of the data underlying FDA's advisory, and to hold a public meeting on the product.

November 16, 2017 | Daily News

The Part D rule that CMS proposed Thursday (Nov. 16) targets pharmacy benefit managers by proposing to make the middlemen share rebates and other pharmacy fees with beneficiaries, instead of pocketing those savings.

November 16, 2017 | Daily News

CMS is taking steps that would let Medicare Part D plan sponsors establish drug management programs for beneficiaries considered at risk for abuse of drugs identified as frequently abused under the Comprehensive Addiction and Recovery Act (CARA).

November 16, 2017 | Daily News

FDA has introduced a new risk-based framework, accompanied by two final guidances and two new draft guidances, for regulating regenerative medicines, the agency announced Thursday (Nov. 16).

November 16, 2017 | Daily News

The White House Office of Management and Budget is done reviewing a proposed rule on Part D and Medicare Advantage, according to the OMB website, and drug industry lobbyists expect CMS to publish the rule Friday (Nov. 16).

November 15, 2017 | Daily News

Reps. David McKinley (R-WV) and Mike Thompson (D-CA) introduced legislation to stop CMS from cutting hospital pay for 340B drugs in 2018.

November 15, 2017 | Daily News

FDA has approved marketing approval of a device -- the first of its kind -- that can help provide patients with relief from opioid withdrawal systems, the agency announced Wednesday (Nov. 15).

November 15, 2017 | Daily News

The House on Wednesday (Nov. 15) passed by voice vote legislation that would preserve FDA's role in approving emergency medical products needed for troops -- a deal that FDA and the White House helped broker to clarify controversial language in the 2018 Defense authorization bill that would have given the emergency approval role to the Department of Defense (DOD).

November 15, 2017 | Daily News

FDA has approved the first drug in the United States embedded with an ingestible sensor that records when the medication is taken, the agency announced Monday (Nov. 13).

November 15, 2017 | Daily News

FDA may withdrawal a regulation related to drug irradiation and requirements that certain medical device submissions be submitted via paper copy, HHS Associate Deputy Secretary Charles Keckler told a House Oversight subcommittee during a Tuesday (Nov. 14) regulatory reform hearing.

November 14, 2017 | Daily News

Joe Grogan, the White House Office of Management and Budget’s point person on drug policy, intimated Tuesday (Nov. 14) that there is no drug price executive order in the works and said CMS’ recent biosimilar billing code policy could be re-reversed.

November 14, 2017 | Daily News

FDA and the White House helped to broker a deal preserving the agency's role in approving emergency medical products needed for troops -- a deal that a House leadership aide told Inside Health Policy will be taken up on the House floor Wednesday (Nov. 15).

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