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Rx Drugs

September 24, 2019 | Daily News

The use of medical devices in combination with biologic medicines is emerging as a way to ease burdens on patients and reduce health care costs, but the products pose regulatory challenges to FDA, agency drug center director Janet Woodcock told stakeholders Monday (Sept. 23).

September 24, 2019 | Daily News

FDA officials are encouraging developers of drugs to treat amyotrophic lateral sclerosis (ALS) to get the word out about their research and offer access to their investigational products to patients through the agency’s Right to Try and expanded access pathways.

September 23, 2019 | Daily News

In a brief two-page report, the Government Accountability Office highlights the potential for opioid vaccines and lays out the challenges and policy questions surrounding their development, including what standards FDA should set for clinical trials and what resources would be needed.

September 23, 2019 | Daily News

Compounding company Athenex has withdrawn its appeal of a recent D.C. federal district court ruling that upheld FDA’s ban on bulk compounding of vasopressin.

September 23, 2019 | Daily News

FDA wants input from stakeholders on the development of abuse-deterrent formulations (ADFs) of central nervous system stimulants, which are widely prescribed to treat attention deficit hyperactivity disorder and sometimes narcolepsy.

September 20, 2019 | Daily News

President Donald Trump on Thursday (Sept. 19) issued an executive order to establish a National Influenza Task Force, co-chaired by the heads of HHS and the Department of Defense and comprising senior officials from several federal agencies, including FDA and CMS.

September 19, 2019 | Daily News

FDA plans to reject citizen petitions submitted primarily to delay generic and biosimilar competition, and the agency will refer offenders to the Federal Trade Commission, according to final guidance released Wednesday (Sept. 18).

September 19, 2019 | Daily News

House Speaker Nancy Pelosi (D-CA) on Thursday (Sept. 19) unveiled her long-awaited government price negotiation plan, which would give HHS the power to negotiate drug prices that would apply to all payers.

September 18, 2019 | Daily News

House Speaker Nancy Pelosi (D-CA) will release a bill Thursday (Sept. 19) that directs Medicare to negotiate prices for at least 25 drugs, and up to 250 drugs, according to lawmakers who have been briefed on the bill.

September 17, 2019 | Daily News

House Speaker Nancy Pelosi (D-CA) is expected to release her long-awaited government drug price negotiation plan on Wednesday (Sept. 18).

September 17, 2019 | Daily News

FDA, the National Organization for Rare Disorders and the Critical Path Institute (CBI) launched a data analytics platform that the parties hope will accelerate the development of new cures for rare diseases.

September 16, 2019 | Daily News

Former FDA chief Scott Gottlieb has joined the advisory board of FasterCures, a center of the nonprofit, non-partisan think tank Milken Institute.

September 16, 2019 | Daily News

The medical countermeasure research wing of HHS chose five new groups to be part of a nationwide network meant to help boost the development of new products that could help detect illnesses, reduce the damage caused by sepsis and generally protect against public health threats, HHS announced on Monday (Sept. 16).

September 13, 2019 | Daily News

The California legislature on Thursday (Sept. 12) passed the first state bill discouraging settlements between drug makers that delay generic competition.

September 13, 2019 | Daily News

FDA warned patients and health care professionals on Friday (Sept. 13) that it has discovered low levels of a carcinogenic impurity in some over-the-counter and prescription heartburn and indigestion drugs.

September 12, 2019 | Daily News

Lawmakers and administration officials are slowly backing away from the White House’s promise to roll out a large-scale Affordable Care Act replacement plan and are instead saying the president is focusing on smaller-scale items such as drug pricing and surprise billing, and will take another look at protecting coverage for preexisting conditions if the courts overturn the health law.

September 12, 2019 | Daily News

Sen. Elizabeth Warren (D-MA) added a health care plan, along with policies to control drug prices, to her presidential campaign website hours before she was to take the stage Sept. 12 to debate fellow Democratic candidates.

September 12, 2019 | Daily News

Health care issues made up a large portion of the first two Democratic debates as candidates parried over their respective visions on universal health coverage, and some Democratic strategists say the candidates in tonight’s debate need to also make clear that the Trump administration has been working to undermine the existing law, both through regulatory moves and by backing a lawsuit that aims to scrap the Affordable Care Act.

September 11, 2019 | Daily News

FDA urged compounders to improve their reporting of adverse events after an agency investigation found that one medical product provider had knowledge of more than 4,000 adverse events associated with compounded products that it had never reported to the agency.

September 11, 2019 | Daily News

Former FDA Commissioner Scott Gottlieb said that as FDA stands up a framework for using real-world evidence (RWE) to make postmarket decisions, the health care system will need to have several impartial entities compete in the market to conduct independent, impartial assessments of new therapies.

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