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Rx Drugs

June 03, 2019 | Daily News

If a fiscal 2020 agriculture funding bill passes the House Appropriations Committee on Tuesday (June 4), FDA will be one step closer to receiving millions of dollars to support new oversight efforts in its cosmetics, supplements and food import spaces.

June 03, 2019 | Daily News

Days before the House Appropriations Committee is set to mark up an FDA funding bill, an expert on the agency’s budget process said there are plenty of challenges looming ahead that could sink the $184 million increase that House lawmakers propose in the bill.

June 03, 2019 | Daily News

FDA Chief of Staff Lauren Silvis will leave the agency this month and be replaced by Keagan Lenihan, the agency’s associate commissioner for strategic initiatives and external affairs who has played key roles in the administration’s drug-pricing and drug-shortages initiatives, according to tweets by former FDA Commissioner Scott Gottlieb on Monday (June 3).

May 30, 2019 | Daily News

As FDA weighs how to regulate cannabidiol (CBD) from hemp in food and dietary supplements, the budding industry will hold up a court case from the 1990s to argue that hemp extract with CBD should be allowed in dietary supplements as long as it is not highly concentrated, an industry lawyer said.

May 30, 2019 | Daily News

FDA is considering how it could go about requiring certain opioids to be dispensed in unit-of-dose, or blister, packaging and is seeking input from stakeholders, the agency announced in the Federal Register Friday (May 30).

May 29, 2019 | Daily News

Stakeholders are urging FDA to quickly write regulations to strictly monitor the burgeoning cannabis industry, with one marijuana legalization advocacy group warning the lack of guidance and regulation on manufacturing, marketing, testing and selling products infused with cannabidiol (CBD) is creating an opportunity for “predatory companies” to market potentially unsafe products and is leading to confusion about the legal status and safety of CBD-containing products.

May 29, 2019 | Daily News

FDA’s approval Friday (May 24) of a new drug to treat breast cancer marks the first novel drug that has moved through the agency’s Real-Time Oncology Review (RTOR) Pilot program.

May 29, 2019 | Daily News

If HHS waits until November to ban Medicare drug rebates, consistent with the department’s regulatory agenda, it would be too late to implement the new policy in 2020, sources say.

May 29, 2019 | Daily News

A new CMS bulletin on spread pricing could pave the way for getting Medicaid managed care plans and pharmacy benefit managers to disclose spread-pricing amounts, according to Alex Shekhdar, founder of Sycamore Creek Healthcare Advisors.

May 24, 2019 | Daily News

Maryland on Friday (May 24) became the first state to create a board that will study drug costs, and could be given the power to set drug pay rates. Maryland Gov. Larry Hogan (R) allowed the state legislature’s banner drug-pricing bill to become law without his signature.

May 24, 2019 | Daily News

The dietary supplement industry says FDA should use existing master files to protect the intellectual property of supplement makers, with several industry officials saying such a move would incentivize legitimate companies to continue investing in research.

May 24, 2019 | Daily News

The Federal Trade Commission said on Thursday (May 23) that while brand and generic drug makers settled patent disputes more often in fiscal year 2016 than prior years, only one of the agreements met the Supreme Court’s criteria of potentially being anticompetitive.

May 24, 2019 | Daily News

FDA’s drug center would receive an approximate $50 million increase in budget authority over fiscal 2019 levels under the 2020 funding bill passed by the House Appropriations agriculture subcommittee on Thursday (May 23), according to a preliminary analysis by the Alliance for a Stronger FDA.

May 23, 2019 | Daily News

In a quick turn of events, the focus of drug-pricing legislation in the House shifted from Medicare negotiation to Part D reinsurance reform, which also is the approach that is being considered in the Senate.

May 23, 2019 | Daily News

The House Appropriations agriculture subcommittee on Thursday (May 23) voted to send a fiscal 2020 funding bill that would give FDA a $184 million increase over its fiscal 2019 levels to the full committee.

May 23, 2019 | Daily News

FDA has once again officially delayed its planned release of a highly anticipated nonprescription drug proposed rule, although an FDA official said this week the agency hopes to get the rule out as soon as possible.

May 23, 2019 | Daily News

A drug industry lawyer and a drug regulation expert applauded a recent FDA draft guidance on the use of real-world evidence (RWE) and real-world data (RWD) in drug and biologics applications as a major step forward, but said questions remain related to data quality and informed consent.

May 23, 2019 | Daily News

The Senate health committee’s bipartisan draft bill on lowering health care costs does not expand the Trump administration’s point-of-sale rebate proposal to the commercial market, after Chair Lamar Alexander (R-TN) said the proposal was being considered for inclusion.

May 22, 2019 | Daily News

FDA expects to propose a number of significant new rules over the next year that will address tobacco product applications, warnings for cigarette packages and advertisements, annual reporting requirements for investigational new drugs, and requirements for drug products that are deemed difficult to compound.

May 22, 2019 | Daily News

CMS Administrator Seema Verma on Wednesday (May 22) said the agency is taking its time with a national Medicare coverage policy for new expensive hospital-administered cancer drugs, which was due to be published May 17 but was delayed, because the policy will affect coverage of drugs other than the two chimeric antigen receptor (CAR) T-cell therapies already on the market.

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