Search Results for drug

Showing 1 – 25  of 916

FDA Looks Ahead and Back on Orally Inhaled and Nasal Generic Drugs By Zachary Brennan - Published 15 January 2018

The US Food and Drug Administration (FDA) has come a long way when it comes to locally acting orally inhaled and nasal drug products (OINDPs) and in the next five years of generic drug user fees, the agency is looking at further progress on some unique challenges, according to a regulatory science report on OINDPs.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: OINDP, locally acting orally inhaled and nasal drug products

CDER Report on Novel Approvals Highlights Firsts in 2017 By Zachary Brennan - Published 10 January 2018

2017 was a year of firsts for the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), with initial approvals in at least five medical conditions and other firsts that might not end up on the final scorecard, like the first biosimilar cancer treatment or the first immediate-release opioid with abuse-deterrent properties.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: 2017 novel drug approvals, CDER report, Woodcock, Gottlieb

House E&C Offers Recommendations to Improve 340B Drug Pricing Program By Zachary Brennan - Published 10 January 2018

The House Energy & Commerce (E&C) Committee on Wednesday released an 80-page report outlining issues related to the 340B drug pricing program, which helps reduce the prices of certain drugs for participating hospitals, health centers and other entities that provide care for vulnerable patients, and recommendations to improve the program’s administration.

Categories: News, US, Drugs, Government affairs, Reimbursement

Tags: HRSA, 340B, drug discount, House Energy & Commerce

HHS Secretary Nominee: 'No Silver Bullet' to Bring Down Drug Prices By Zachary Brennan - Published 09 January 2018

President Donald Trump's Department of Health and Human Services (HHS) Secretary nominee Alex Azar told the Senate Finance Committee on Tuesday that drug prices "are too high" and he will work to bring them down, though, "There's no silver bullet."

Categories: News, US, FDA, Drugs, Government affairs

Tags: drug prices, Alex Azar, Senate Finance

Industry Groups Explain Competition Issues in the US Pharma Market By Zachary Brennan - Published 05 January 2018

Industry groups representing generic and brand-name drugs, pharmacy benefit managers (PBMs) and pharmacies offered their comments on a November meeting held at the Federal Trade Commission (FTC) on possible solutions to increase competition and lower drug prices in the US.

Categories: News, US, FDA, FTC, Generic drugs

Tags: drug prices, pharmaceutical competition

HHS' OIG to PhRMA: Free Pharmaceuticals Needed in 2018 By Zachary Brennan - Published 05 January 2018

With a nonprofit that paid almost $100 million in 2015 financial grants to patients now saying that it will not offer such payments in 2018, Gregory Demske, chief counsel to the Department of Health and Human Services' Office of the Inspector General (OIG), sent a letter on Thursday seeking help from the pharmaceutical industry group PhRMA in providing free drugs.

Categories: News, US, Drugs, Government affairs, Reimbursement

Tags: PhRMA, CVC, drug charity, OIG

More Than 100 Days After Hurricane Maria, Drug Shortages Situation Expected to Improve By Zachary Brennan - Published 04 January 2018

The US Food and Drug Administration (FDA) on Thursday announced that shortages of IV saline are expected to improve early this year as Baxter – a leading producer of IV saline fluids – has said all its facilities on Puerto Rico have now returned to the commercial power grid.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs

Tags: drug shortages, Baxter, IV saline, Puerto Rico, Hurricane Maria

FDA Targets Multiple Review Cycles With New Draft Guidance, MAPP By Zachary Brennan - Published 03 January 2018

Fresh out of a record year for generic drug approvals, the US Food and Drug Administration (FDA) on Wednesday kicked off the new year by releasing new draft guidance and a new manual of policies and procedures (MAPP) with an eye toward decreasing the number of review cycles abbreviated new drug applications (ANDAs) undergo before approval.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: ANDA review cycles, generic drug guidance, MAPP

OPDP Letters: FDA Closes Out 2017 With Record Low By Michael Mezher - Published 03 January 2018

In the last days of 2017, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to over-the-counter (OTC) drugmaker Avanthi, Inc. for omitting risk information in a panel for the weight loss drug Lomaira (phentermine hydrochloride USP).

Categories: News, US, FDA, Advertising and Promotion, Drugs

Tags: OPDP, Prescription Drug Promotion, Warning Letter

Ruling Against Novartis Could Have Wider Implications for Generic Drug Labels By Zachary Brennan - Published 22 December 2017

California's Supreme Court on Thursday ruled against Novartis in a decision that could have wider implications for whether brand-name or generic drugmakers should be held liable for warning consumers of risks in their drug labels.

Categories: News, US, FDA, Drugs, Government affairs, Labeling, Regulatory strategy, Submission and registration

Tags: generic drug labels, label proposed rule, rulemaking

Updated: New Drug Approvals for FDA: 2017 Hits 21-Year High By Zachary Brennan - Published 21 December 2017

The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies approved this year) has now topped the highest number of NMEs approved in any year except 1996.

Categories: News, US, FDA, Drugs, Government affairs, Submission and registration

Tags: new drug approvals, new molecular entities, Addyi,

GAO: Retail Drug Price Expenditures Have Nearly Doubled Since 1990s By Zachary Brennan - Published 19 December 2017

The US Government Accountability Office (GAO) on Tuesday released a new report on the pharmaceutical industry's sales and expenses related to research and development (R&D), noting that the amount of money people spend on prescription drugs has nearly doubled since the 1990s, mostly because of brand-name drugs.

Categories: News, US, DOJ, FDA, FTC, Biologics and biotechnology, Drugs, Government affairs, Research and development

Tags: GAO report, drug prices, R&D spending

Senate, House Agree to Cut Orphan Drug Research Credit in Half in Tax Bill By Zachary Brennan - Published 18 December 2017

Members of the House-Senate Conference Committee discussing the GOP's tax overhaul plan on Friday released the final text of the bill, which would reduce the rare disease research tax credits biopharma companies can claim by half.

Categories: News, US, Clinical, Orphan products, Research and development

Tags: orphan drug research, research tax credit, tax bill

FDA to Pharma Firms: Update or Certify Drug Listings by End of Month Published 14 December 2017

To ensure the National Drug Code directory is accurate, the US Food and Drug Administration (FDA) on Thursday sent a reminder to pharmaceutical companies that 31 December 2017 is the deadline by which the firms must update or certify their drug listings with FDA via electronic format.

Categories: News, US, FDA, Compliance, Drugs, Due Diligence

Tags: drug listings, Part 207 of Title 21

Updated: Generic Drug Monthly Dashboard: FDA Adds New Metrics By Zachary Brennan - Published 13 December 2017

The US Food and Drug Administration (FDA) last month began releasing new information a monthly basis related to generic drugs.

Categories: News, US, FDA, Generic drugs

Tags: generic drug activity, GDUFA II

FDA Finalizes Guidance on Promotional Drug Labeling and Ads By Zachary Brennan - Published 11 December 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs.

Categories: News, US, FDA, Advertising and Promotion, Drugs

Tags: drug labeling, promotional and advertising guidance FDA, deceptive pharma ads

HHS Secretary Nominee Azar: Top Priority is Drug Prices By Zachary Brennan - Published 29 November 2017

The Senate Health, Education, Labor and Pensions Committee hearing on Wednesday grilled President Donald Trump's HHS secretary nominee and former Eli Lilly executive Alex Azar on drug prices, and he vowed that the issue would be his top priority.

Categories: News, US, Drugs, Government affairs, Regulatory intelligence

Tags: HHS Secretary, Rand Paul, Elizabeth Warren, drug prices

IGDRP Offers Guidance for Quality Assessors on Drug Substances By Zachary Brennan - Published 28 November 2017

The International Generic Drug Regulators Programme (IGDRP) on Tuesday released guidance finalized in June to help regulatory agencies’ quality assessors review technical information on active substances.

Categories: News, Canada, Europe, ICH, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: IGDRP, international regulation, drug substance

Administering the Hatch-Waxman Amendments: Industry, Academics and Senator Discuss Balance By Zachary Brennan - Published 27 November 2017

The US Food and Drug Administration (FDA) has made it a priority to find a balance between encouraging innovative medical products and increasing access to lower-cost pharmaceuticals under the Hatch-Waxman Act 1984. But when it comes to finding ways to speed the influx of generic drugs and stop frequently cited abuses, a host of voices from industry, academia and Congress are offering differing views.

Categories: News, US, FDA, Compliance, Drugs, Government affairs, Labeling

Tags: Hatch-Waxman, generic drug competition, CREATES Act

Stakeholders Weigh FDA Proposal to Limit Risk Info in DTC Advertisements By Zachary Brennan - Published 27 November 2017

Industry and pharmacy groups generally support the US Food and Drug Administration's (FDA) proposal to limit the amount of risk information presented in pharmaceutical direct-to-consumer (DTC) advertisements, though others have criticized the plan and research backing it as flawed.

Categories: News, US, FDA, Advertising and Promotion, Drugs

Tags: DTC drug advertisements, risk information in drug ads

FDA Issues Delayed DSCSA Grandfathering Guidance By Michael Mezher - Published 27 November 2017

The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing its policy for when packages and homogenous cases of drugs without a product identifier are grandfathered from certain provisions of the Drug Supply Chain Security Act (DSCSA).

Categories: News, US, FDA, Distribution, Drugs

Tags: DSCSA, Drug Supply Chain Security Act, Grandfathered, Product Identifier

Updated: House Passes GOP Tax Overhaul With Orphan Drug Tax Credit Repeal Included By Zachary Brennan - Published 16 November 2017

The US House of Representatives on Thursday passed a bill to reform the US tax code by a vote of 227 to 205, with all Democrats voting against it and all but 13 Republicans voting for it.

Categories: News, US, FDA, Clinical, Reimbursement, Research and development

Tags: orphan drug tax credit, tax reform

Drug Labels: Experts Note Importance of Faster Updates By Zachary Brennan - Published 15 November 2017

The topic of cancer drug labels and how they can be updated more quickly, as well as how the labeling system needs to be reformed was front and center at several panels at the Friends of Cancer Research's annual meeting in Washington, D.C. on Wednesday.

Categories: News, US, FDA, Drugs, Government affairs, Labeling

Tags: drug labels, cancer drug labels, Friends of Cancer Research

Senate Tax Plan Seeks to Reform, Rather Than Repeal, Orphan Drug Tax Credit By Zachary Brennan - Published 10 November 2017

The Senate’s tax plan, running counter to the House’s call to eliminate the orphan drug tax credit for research on drugs to treat rare diseases, seeks to modify the credit instead.

Categories: News, US, Clinical, Research and development

Tags: GOP tax plan, Senate tax reform, Hatch, orphan drug tax credit

FDA Expands Generic Drug Priority Reviews By Zachary Brennan - Published 09 November 2017

Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever – a trend likely to continue.

Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: generic drug review, generic drug approval, GDUFA