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Gottlieb's FDA

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.

November 29, 2018 | Daily News

A device industry lawyer alleges that FDA’s proposals to reform its 510(k) process violates the agency’s statutory authority, threatens to monkey around with the device market, and would increase the cost of device innovation and health care more generally.

November 29, 2018 | Daily News

A medical device expert and former FDA staffer says that the Medical Device Enforcement and Quality Report released by FDA on Nov. 21 appears intended to dispel criticism that the agency does not take sufficient enforcement action when appropriate while also appealing to Congress for help with funding for device-related postmarket activities.

November 29, 2018 | Daily News

FDA Commissioner Scott Gottlieb on Wednesday (Nov. 28) took to Twitter to condemn a Chinese researcher who made headlines after announcing he had edited the genes of a set of twin girls born this month using the CRISPR-Cas 9 gene editing tool.

November 29, 2018 | Daily News

FDA once again issued a warning letter to an e-cigarette company for selling e-cigarette e-liquids with labeling or advertising that resembles kid-friendly food products and for illegally selling to a minor.

November 28, 2018 | Daily News

A day after releasing a plan to overhaul FDA’s clearance process for certain low- and moderate-risk medical devices, FDA Commissioner Scott Gottlieb defended his agency’s proposals amidst a wave of industry opposition to them and used cybsecurity concerns to make his point.

November 27, 2018 | Daily News

The International Consortium of Harmonisation agreed with FDA Commissioner Scott Gottlieb this month that its members should develop standard international approval requirements for generic drugs, which would facilitate simultaneous approvals in multiple markets.

November 27, 2018 | Daily News

Continuing drug shortage issues are a result of economic and policy failures that span many years, FDA Commissioner Scott Gottlieb told a crowd of researchers, health care providers, industry representatives and other experts during the agency’s Tuesday (Nov. 27) drug shortages public meeting, held in coordination with the Duke Margolis Center for Health Policy.

November 26, 2018 | Daily News

Device industry leaders were taken aback that FDA is considering publishing online the names of devices cleared using predicate devices that are 10 years old or older -- a move the agency announced Monday (Nov. 26) as part of a broader effort to modernize and tighten its medical device clearance process amid recent reports of safety issues.

November 26, 2018 | Daily News

FDA Commissioner Scott Gottlieb called low prices and CMS reimbursement for generic prescription drugs a “root cause” of drug shortages in a blog post he co-authored with the agency’s drug center chief, Janet Woodcock, last week.

November 21, 2018 | Daily News

As pharmacy and other health care stakeholders convened last week to discuss myriad issues surrounding illegal online sales of prescription drugs, one FDA official called for companies that manage and sell internet domain names to ramp up enforcement of their terms of use agreements and stop allowing violative website operators to continue leasing domains under different website names. This, the official said, would help fix the whack-a-mole issue on FDA’s side of enforcement.

November 21, 2018 | Daily News

One industry lawyer found that FDA has put out many more new rules for the food and medical device industries over the past six years than it has for other industries, such as drugs, biologics, cosmetics and animal feed.

November 20, 2018 | Daily News

FDA Commissioner Scott Gottlieb on Monday (Nov. 19) introduced a new risk-based framework for how the agency will regulate software products that are designed to be used in conjunction with prescription drugs, also known as prescription drug-use-related software.

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