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Gottlieb's FDA

May 17, 2018 | Daily News

The House will vote next week on the Right to Try bill passed out of the Senate last August, House leadership said Thursday.

May 17, 2018 | Daily News

FDA's long-awaited list of brand drugs for which generics have sought the agency's help in obtaining the samples necessary for testing and approval confirms that Risk Evaluation and Mitigation Strategies are not the only tool used by brands to withhold samples.

May 17, 2018 | Daily News

FDA on Wednesday (May 16) approved US WorldMeds LLC’s Lucemyra, the first agency-approved non-opioid treatment for mitigating the symptoms of opioid withdrawal.

May 17, 2018 | Daily News

FDA, as it crafts a new framework to regulate artificial intelligence used in medical products, is simultaneously partnering with Harvard to look into how AI also could be used as a regulatory tool.

May 16, 2018 | Daily News

The House Appropriations Committee approved Wednesday (May 16) a fiscal 2019 FDA spending bill, and in the process tacked on a controversial tobacco amendment that several Democrats and one Republican argued would essentially rewrite the Tobacco Control Act and weaken FDA’s ability to regulate tobacco products, especially e-cigarettes and cigars that appeal to youth.

May 16, 2018 | Daily News

HHS Secretary Alex Azar is explaining why the president’s newly released drug pricing plan doesn’t deliver on two of President Donald Trump’s campaign promises: direct drug price negotiation in Medicare and allowing importation of cheaper drugs from Canada.

May 15, 2018 | Daily News

Facing a White House mandate to study whether FDA can require disclosure of drug list prices in direct-to-consumer ads, FDA Commissioner Scott Gottlieb insinuated it was an open question whether list prices are the best way to inform consumers of a drug’s potential out-of-pocket cost.

May 15, 2018 | Daily News

FDA Commissioner Scott Gottlieb said Tuesday (May 15) that the upcoming guidance on waiving the requirement that brands and generics share a safety system will be short and simply put brands on notice that FDA is ready, willing and able to waive the requirement when it is blocking generic competition -- despite an earlier prediction from a policy watcher close to the issue that the guidance would lay out specific steps each party must go through before FDA can waive the requirement.

May 15, 2018 | Daily News

FDA Commissioner Scott Gottlieb has fulfilled his promise to contact supply chain intermediaries and discourage them from entering into so-called voluntary restricted distribution systems that block generic companies from buying samples needed for FDA-required testing, however his pressure to date has not been successful.

May 14, 2018 | Daily News

FDA soon will announce a set of reforms intended to make the new drug approval process more efficient and spur innovation, FDA Commissioner Scott Gottlieb told reporters during a Monday (May 14) media briefing.

May 14, 2018 | Daily News

FDA is expected to, as early as Thursday (May 17), unveil a new web page on which it will initially publish 150 letters sent by the agency to brand companies explaining that a potential generic competitor has adequate safety protections in place to receive the brand drug samples for bioequivalence testing, FDA Commissioner Scott Gottlieb and HHS Secretary Alex Azar announced Monday (May 14).

May 14, 2018 | Daily News

Some stakeholders are questioning the usefulness of the unified agenda in mapping out what regulatory actions FDA plans to take in the next 12 months, despite the White House’s claims that it has taken steps to make the semi-annual regulatory plan more useful to stakeholders.

May 14, 2018 | Daily News

FDA and producers of so-called abuse-deterrent formulations of opioids -- dubbed ADFs -- are expected to discuss at an upcoming meeting whether the words “abuse-deterrent” should be changed or better described when associated with such products, coming as the agency also faces pressure from Congress to broach the issue.

May 11, 2018 | Daily News

Many of the policies in the president’s drug price plan put the onus on patients to get cheaper drugs: such as including prices in drug ads, giving patients information on competing drug prices during office visits, posting drug prices on Medicare’s “dashboard” website and banning gag orders that stop pharmacists from telling customers when it is cheaper to buy drugs without insurance.

May 11, 2018 | Daily News

Stakeholders are questioning the usefulness and feasibility of the White House’s idea of requiring drug prices be disclosed in direct-to-consumer ads -- with some saying the idea would not survive a First Amendment challenge and others asserting including list prices could mislead consumers.

May 10, 2018 | Daily News

The president’s plan for lowering drug costs includes four strategies that senior administration officials say can be done without congressional help: Stop drug makers from gaming rules to thwart generic and biosimilar competition; remove government rules that prevent health plans from negotiating better deals, especially on expensive drugs; create incentives to lower drug list prices; and lower beneficiaries’ out-of-pocket spending.

May 10, 2018 | Daily News

FDA on Thursday (May 10) issued four warning letters to tobacco retailers for marketing and selling flavored tobacco products sold in packages and flavors that mimic kid-friendly foods, including cereal, soda and pancakes -- all of which, FDA notes, could kill a young child if less than a teaspoon was ingested.

May 10, 2018 | Daily News

A coalition of over 80 groups, including manufacturers, providers, laboratories and patient advocates, sent a letter Wednesday (May 9) to key members of Congress attempting to create momentum around passing legislation in 2018 revising government oversight of diagnostics, including laboratory developed tests (LDTs).

May 09, 2018 | Daily News

In the next 12 months FDA plans to write safety standards for e-liquids and establish regulations for detaining tobacco products believed to be misbranded during inspections, according to the agency's spring 2018 regulatory agenda.

May 08, 2018 | Daily News

On the heels of FDA’s first approval of a tissue-agnostic cancer treatment, cancer research advocates are eagerly awaiting an FDA public workshop scheduled for Wednesday (May 9) on the scientific and regulatory issues associated with granting orphan drug designation to these therapies.

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