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Gottlieb's FDA

July 06, 2018 | Daily News

FDA published final guidance on Wednesday (July 3) that sets out classifications and categories for amendments to generic drug applications and how amendment submissions may affect an application's review goal dates.

July 05, 2018 | Daily News

In an agency-wide email and a report sent to Congress, FDA lays out its plans for enhancing its hiring processes to improve recruitment and retention.

June 26, 2018 | Daily News

FDA soon will publish a list of surrogate endpoints that have already been used as the basis for drug and biologics approvals, FDA Commissioner Scott Gottlieb told stakeholders Monday (June 25).

June 22, 2018 | Daily News

A representative of an independent device service organization called out other ISOs for servicing medical devices without proper equipment or training, a concern which FDA said in a report released last month did not have enough evidence to be considered a widespread public health risk.

June 19, 2018 | Daily News

Facing pressure from appropriators, lawmakers and stakeholders, FDA signaled Tuesday (June 19) it is rethinking its controversial move to require pure maple syrup and pure honey be labeled as having “added sugar.”

June 18, 2018 | Daily News

Lawyers representing outsourcing compounders are signaling they may sue FDA should it finalize guidance outlining its plans to evaluate whether there is a clinical need to compound a drug using bulk active pharmaceutical ingredients.

June 18, 2018 | Daily News

Senators from both parties urged FDA Commissioner Scott Gottlieb to keep up the pressure on CMS to add medical device identifier information to Medicare claims forms, a change which FDA expressed support for in the Medical Device Safety Action Plan it released in April.

June 15, 2018 | Daily News

FDA will hold a public meeting July 12 to gather stakeholders' input on how the agency should regulate foods resembling meat, poultry and seafood that are produced using small amounts of cells from the animal that the food product is supposed to resemble, a development already protested by the cattlemen’s association as usurping USDA's authority over what the group calls “fake meat.”

June 15, 2018 | Daily News

FDA's decision to adopt a hands-off approach on medical device servicing has refueled congressional interest in legislation to beef up federal oversight of the industry, a spokesperson for the House Energy and Commerce Committee told Inside Health Policy.

June 15, 2018 | Daily News

The Medical Imaging & Technology Alliance (MITA) is working with device industry stakeholders on a nationwide voluntary standard for the servicing of medical devices, coming as FDA advocates a hands-off regulatory approach toward servicers, a MITA policy expert told Inside Health Policy.

June 13, 2018 | Daily News

FDA Commissioner Scott Gottlieb said he is discussing with CMS the possibility of a new license-based reimbursement model for antibiotics that would spare drug makers some of the disincentives that come with antibiotic development, such as the low volume of sales that occur when providers try to use antibiotics sparingly.

June 12, 2018 | Daily News

FDA finalized Tuesday (Jun 12) two guidances clarifying FDA’s rules for communicating health care economic information with payers and for promoting information that is consistent with, but absent from, a product’s label.

June 12, 2018 | Daily News

HHS Secretary Alex Azar told the Senate health committee Tuesday (June 12) that he believes the administration has the authority to mandate disclosure of list prices in direct-to-consumer ads, but added that he welcomes congressional action on the issue given he expects the idea will be challenged in court.

June 12, 2018 | Daily News

Rep. Doris Matsui (D-CA) on Tuesday (June 12) introduced a provider-friendly bill to reform the 340B drug discount program -- including explicitly laying out a purpose for the 340B program that says hospitals do not necessarily have to forward drug discounts to patients and reversing the CMS cut to hospitals' Medicare reimbursement for 340B drugs.

June 11, 2018 | Daily News

Top House Energy & Commerce members from both parties raised concerns FDA is not following through on its plan to use $94 million from Congress to double down on efforts to keep illegal opioids from entering the United States through international mail facilities.

June 08, 2018 | Daily News

The future of FDA's proposed reorganization of its Office of New Drugs is unclear, as Congress must approve the agency's proposal before it can move forward.

June 07, 2018 | Daily News

FDA tells Congress it is weighing how to prevent brand drug makers from trying to use the citizen petition process to delay competition, and one industry attorney predicts FDA could issue guidance outlining when it can invoke a statutory provision allowing the agency to deny petitions primarily meant to delay competition.

June 06, 2018 | Daily News

After FDA and the U.S. Department of Agriculture announced this week they will harmonize their audits of produce facilities, FDA Commissioner Scott Gottlieb told Inside Health Policy the two agencies will succeed this time around, when they failed previously, in their broader effort to eliminate inefficiencies stemming from dual-regulation of food facilities.

June 06, 2018 | Daily News

FDA is weighing how to further incentivize testing of previously approved mass-marketed drugs to treat rare diseases, despite the fact that a legislative proposal to do just that has been fiercely contested by drug pricing advocates.

June 05, 2018 | Daily News

FDA sent warning letters to nine online networks operating 53 websites demanding they stop illegally marketing misbranded and unapproved drugs, specifically opioids, the agency announced Tuesday (June 5).