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Gottlieb's FDA

August 03, 2018 | Daily News

FDA this week notified seven device manufacturers that their products are being inappropriately marketed for unapproved “vaginal rejuvenation” procedures, such as treating conditions and symptoms related to menopause, urinary incontinence or sexual function.

August 02, 2018 | Daily News

The vaping industry is speaking out in opposition to a proposed 25 percent tariff on e-cigarettes imported from China, arguing the tariffs would have a negative effect on public health and would exacerbate the regulatory uncertainty created by FDA's tobacco deeming rule.

August 01, 2018 | Daily News

The Senate soundly rejected an amendment proposed by Sen. Mike Lee (R-UT) to the minibus appropriations bill on Wednesday (Aug. 1) that aimed to protect those marketing products using common compound names that identify an alternative plant or animal source, such as almond milk, goat cheese or gluten-free bread, Lee said when he described the measure.

July 31, 2018 | Daily News

The Senate on Tuesday (July 31) passed by voice vote the Animal Drug User Fee and Animal Generic Drug User Fee Amendments (ADUFA/AGDUFA), which reauthorize FDA’s animal drug and generic drug user fee programs.

July 31, 2018 | Daily News

Tobacco industry groups argue that FDA's efforts to set a maximum nicotine standard for combustible tobacco products may violate the Food, Drug and Cosmetic Act (FDCA) and Administrative Procedure Act (APA) because there is a lack of scientific evidence showing a reduction would be appropriate for protection of public health and because reducing nicotine levels to a proposed range of .3 to .5 milligrams per gram of tobacco filler is technically impossible to achieve due to the currently available manufacturing and processing methods.

July 30, 2018 | Daily News

The American Pharmacists Association (APhA) is urging FDA to include a role for pharmacists as it moves forward on a plan to let nonprescription drug makers provide information about their products' safety and efficacy beyond what's on the drug facts label.

July 27, 2018 |

FDA aims to reform the clinical trial space in a way that could help bring more second- and third-in-class drugs to the market, FDA Commissioner Scott Gottlieb told lawmakers on Wednesday (July 25).

July 27, 2018 | Daily News

FDA aims to reform the clinical trial space in a way that could help bring more second- and third-in-class drugs to the market, FDA Commissioner Scott Gottlieb told lawmakers on Wednesday (July 25).

July 27, 2018 | Daily News

FDA soon will make public information about how it could improve its Expanded Access program, based on an assessment by an outside company, FDA Commissioner Scott Gottlieb said at a House Energy & Commerce health subcommittee hearing Wednesday (July 25).

July 27, 2018 | Daily News

FDA finalized plans Thursday (July 26) to stop granting orphan-drug designations, which come with seven years of exclusivity, to drugs for pediatric subpopulations of common diseases.

July 27, 2018 | Daily News

Stakeholders are set to debate Sept. 4 whether FDA's so-called umbrella exclusivity policy will apply to biologics and biosimilars.

July 26, 2018 | Daily News

FDA will reevaluate standards of identity (SOI) for certain foods -- including a look a potential health issues posed by non-dairy milk and cheese products -- as 300 of the current standards are outdated and in need of an updated framework, FDA Commissioner Scott Gottlieb said in a statement Thursday (July 26).

July 23, 2018 | Daily News

Hours after being sued by the consumer advocacy group Public Citizen for allowing the compounding of cesium chloride, FDA agreed to the group's request in a December 2017 petition that cesium chloride be added to an interim list of bulk drug substances that are unsafe for use in compounding.

July 23, 2018 | Daily News

FDA's final guidance on the use of electronic health record (EHR) data in clinical investigations is significantly different from the draft version, which drug and device industry groups had argued put too much burden on sponsors to verify electronic data.

July 23, 2018 | Daily News

FDA Commissioner Scott Gottlieb said his agency and the U.S. Department of Agriculture are still working out how the federal bodies will regulate cultured meats -- 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 -- but he reaffirmed that FDA will definitely play a key role in overseeing the budding industry.

July 23, 2018 | Daily News

As FDA looks to take on regulation of cultured meat, three leading consumer advocacy groups are urging the agency to pursue a new oversight strategy that is more stringent than the generally recognized as safe (GRAS) approach currently used for new food ingredients.

July 20, 2018 | Daily News

FDA drug center Director Janet Woodcock on Thursday (July 19) provided her staff with details on the proposed reorganization of the center, saying the plan, which has been submitted to HHS for approval, involves structural changes within the center's four offices.

July 20, 2018 | Daily News

Bayer will stop selling and distributing its permanent birth control device Essure after Dec. 31 citing commercial reasons, FDA announced Friday (July 20), coming three months after the agency limited Essure to prescription-only in the face of years of adverse events and congressional pressure to step up its oversight.

July 18, 2018 |

FDA released a long-awaited Biosimilars Action Plan Wednesday (July 18) that promises new development tools for biosimilars makers, additional educational resources and a public hearing dedicated to biosimilar competition, among other initiatives.

July 18, 2018 | Daily News

FDA released a long-awaited Biosimilars Action Plan Wednesday (July 18) that promises new development tools for biosimilars makers, additional educational resources and a public hearing dedicated to biosimilar competition, among other initiatives.

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