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Gottlieb's FDA

December 13, 2018 |

The Congressional Budget Office’s Dec. 7 publication of its cost estimate for the Senate’s over-the-counter monograph reform bill bolstered stakeholders’ hopes that the bill might pass the upper chamber before the end of the lame-duck session.

December 13, 2018 | Daily News

The Congressional Budget Office’s Dec. 7 publication of its cost estimate for the Senate’s over-the-counter monograph reform bill bolstered stakeholders’ hopes that the bill might pass the upper chamber before the end of the lame-duck session.

December 12, 2018 | Daily News

Heading into 2019, FDA plans to step up pharmaceutical enforcement and improve its inspection assessments using digital tools, FDA Commissioner Scott Gottlieb said Wednesday (Dec. 12).

December 12, 2018 | Daily News

FDA issued final guidance intended to clarify the role data integrity plays in current good manufacturing practices (CGMP) for drugs and to promote partnerships between FDA and its international regulatory counterparts on best practices on data security to help manufacturers advance their own compliance policies, FDA Commissioner Scott Gottlieb said Wednesday (Dec. 12).

December 12, 2018 | Daily News

FDA Commissioner Scott Gottlieb announced his agency will be discussing how to crack down on bad actors within the dietary supplement industry, including forming a working group to analyze how FDA could improve its oversight, reexamining the agency’s operating procedures, and potentially asking Congress for new authority in the space.

December 11, 2018 | Daily News

FDA announced Tuesday (Dec. 11) in new guidance documents that when insulin is reclassified from a drug to a biologic in 2020, it will not qualify for the 12-year exclusivity that new biologics receive.

December 11, 2018 | Daily News

FDA on Tuesday (Dec. 11) issued a proposed rule and a batch of guidance documents aimed at spurring biologics competition by bringing more biosimilars to market.

December 10, 2018 | Daily News

FDA released new draft guidance on Monday (Dec. 10) that agency head Scott Gottlieb and Deputy Commissioner Anna Abram say will make it more feasible for compounding pharmacies to become outsourcing facilities and ensure those facilities maintain current good manufacturing practices (CGMP).

December 10, 2018 | Daily News

FDA issued the interim results of agency-mandated duodenoscope reprocessing studies to help inform hospitals and health care facilities of the need to carefully clean and properly maintain the devices, the agency said Monday (Dec. 10).

December 07, 2018 | Daily News

FDA’s Bob Temple, a drug center veteran of 46 years, will soon become senior advisor for the Office of New Drugs’ Immediate Office -- becoming the center’s point person on medical decisions that are controversial, complex or critical, center director Janet Woodcock said in an internal email on Friday (Dec. 7).

December 07, 2018 | Daily News

Industry lawyers expect more in vitro diagnostic test makers to apply for CLIA waivers thanks to newly issued FDA guidances that make the process less prescriptive and clarify that tests for which trained and untrained users get comparable results are entitled to a waiver.

December 07, 2018 | Daily News

Thirteen Democratic senators are urging FDA Commissioner Scott Gottlieb to take stronger steps to prevent and reduce youth use of e-cigarettes by including mint- and menthol-flavored e-cigarettes among the types of products that would require stricter age verification and sales practices.

December 06, 2018 | Daily News

Through its new real-world evidence framework, FDA will evaluate how RWE can be used to support changes to labeling about a drug or biologic product’s effectiveness.

December 06, 2018 | Daily News

In a surprise move Thursday (Dec. 6), bipartisan duos of House and Senate lawmakers released draft legislation that lays out a framework for FDA to regulate in vitro clinical tests, such as test kits and laboratory developed tests (LDTs).

December 06, 2018 | Daily News

To mitigate drug shortages, a not-for-profit generic drug company is proposing FDA, on its own and through collaboration with other government agencies, provide manufacturers with myriad incentives, including: reduced regulatory oversight, increased time between inspections, tax credits or federal grants, and fee waivers for certain generic companies.

December 05, 2018 | Daily News

A device and diagnostics lawyer says FDA’s formal recognition of a public database of information about genes, genetic variants and their relationship to disease could help new genetic tests reach market.

December 04, 2018 | Daily News

A medical device industry expert told Inside Health Policy he expects a new proposed rule published by FDA on the de novo pathway will go a long way towards clarifying the process for device manufacturers, helping FDA reach the performance goals laid out by Congress and helping the agency achieve its goals of modernizing the 510(k) premarket notification process.

December 03, 2018 | Daily News

In a further bid to streamline generic drug development, FDA on Monday (Dec. 3) clarified the procedures for generic drug makers to request meetings with the agency after receiving complete response letters (CRL) indicating deficiencies in their applications.

November 30, 2018 | Daily News

In advance of World AIDS Day on Dec. 1, FDA announced a pilot program with the World Health Organization (WHO) that would provide WHO with FDA reviews of new HIV drug applications, thereby allowing WHO to make regulatory decisions about the new drugs faster and to share their decisions with regulators in developing countries with HIV-affected patient populations, FDA writes.

November 30, 2018 | Daily News

After six months and over 250 applications, FDA finally announced the eight winners of an innovation challenge in which medical device developers submitted to the agency their best ideas for preventing and treating opioid addiction.

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