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Rx Drugs

October 10, 2017 | Daily News

FDA has authorized importation of four drugs from Europe in response to shortages caused by Hurricane Maria.

October 10, 2017 | Daily News

A bipartisan group of 54 House lawmakers on Oct. 3 asked CMS to force plans and pharmacy benefit managers to give Part D beneficiaries a larger share of rebates, discounts and pharmacy price concessions.

October 10, 2017 | Daily News

The White House Office of Management and Budget is reviewing a proposed rule on 340B ceiling prices and manufacturer penalties following the Trump administration's fourth delay of a final rule on the same topic put out by the Obama administration.

October 06, 2017 | Daily News

For the first time, FDA has awarded research grants intended to fund natural history studies of rare diseases, the agency announced Friday (Oct. 6).

October 06, 2017 | Daily News

One key Democratic senator has introduced a bill that would strip tribes of their sovereign immunity under the inter partes review process, which if passed would effectively kill the idea of selling drug patents to tribes in an effort to shield those patents from the IPR process.

October 06, 2017 | Daily News

The patient group behind the first-ever externally-led Patient Focused Drug Development (PFDD) meeting is now urging FDA to commit to using this data as part of the agency's review of medical products, and to transparently outline how it directs reviewers to consider the data.

October 06, 2017 | Daily News

Coming as FDA Commissioner Scott Gottlieb pushes to reform the clinical trial process, drug center chief Janet Woodcock rebuffed arguments by some that regulators should eliminate existing global consensus regulations on trial practices because they increase drug development costs.

October 05, 2017 | Daily News

House Energy & Commerce oversight Chair Tim Murphy's (R-PA) announcement Thursday (Oct. 5) he will resign this month comes as the subcommittee steps up its probe into the 340B drug discount program and investigates the healthcare industry's response to malware threats.

October 05, 2017 | Daily News

Specialists are getting help from House Republican lawmakers in their quest to exclude the cost of drugs they administer from the calculation of their Medicare bonuses and penalties.

October 05, 2017 | Daily News

FDA Commissioner Scott Gottlieb wants to work with Congress to expand the agency's ability to seize opioids being smuggled into the United States through international mail facilities (IMFs), the commissioner said during a Senate health committee hearing on the federal response to the opioid epidemic.

October 05, 2017 | Daily News

The Senate health committee will hold the second of three planned hearings on drug pricing and the drug delivery system Tuesday Oct. 17, the committee announced Thursday (Oct. 5).

October 05, 2017 | Daily News

The House Energy & Commerce oversight subcommittee is continuing its investigation into the 340B drug discount program with another hearing Oct. 11 on how providers use the program, the committee announced Wednesday (Oct. 4).

October 04, 2017 | Daily News

FDA approved a record number of generic applications in fiscal 2017, according a former FDA official's analysis of data released Wednesday (Oct. 4).

October 04, 2017 | Daily News

FDA released draft guidance this week aimed at facilitating development of one class of high-cost, widely sold complex drugs that currently lack generic competition.

October 04, 2017 | Daily News

Part of FDA Commissioner Scott Gottlieb’s generic competition plan centers on embracing use of advanced computational modeling for generic drug development and review, the commissioner told generic drug stakeholders Monday (Sept. 2).

October 04, 2017 | Daily News

Should Allergan's controversial patent deal with the Saint Regis Mohawk Tribe hold up and delay generic competition for Restasis until 2024, the deal would cost the U.S. health care system $10.7 billion in lost savings, group purchasing organization Vizient estimates.

October 03, 2017 | Daily News

FDA Commissioner Scott Gottlieb urged lawmakers Tuesday (Oct. 3) to revamp the Senate-passed Right to Try legislation now pending in the lower chamber by narrowing the patient population covered, further restricting promotion and commercialization of the experimental drugs, ensuring FDA’s authority to take certain enforcement actions and protecting FDA from federal tort liability.

October 03, 2017 | Daily News

CMS withdrew the Obama administration's controversial stalled Part B drug pay demonstration Tuesday (Oct. 3), saying the complexity of the model design and desire to include more stakeholder input led to the agency's decision to withdraw the proposed rule.

October 03, 2017 | Daily News

Heads of the House Oversight Committee appear to be looking into a controversial deal between Allergan and the Saint Regis Mohawk Tribe consummated to dodge patent challenges under the inter partes review process, requesting Wednesday (Oct. 3) Allergan's CEO turn over all documents surrounding the deal.

October 03, 2017 | Daily News

FDA and the Federal Trade Commission will hold a public workshop Nov. 8 to examine factors that prevent generic competition for off-patent drugs, and the ways pharmacy benefit managers and group purchasing organizations affect the prices consumers pay for drugs.

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