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Filtering on: "topics drugs generic drugs"

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FDA Sets Monthly ANDA Records in October By Michael Mezher - Published 14 November 2017

The US Food and Drug Administration (FDA) in October issued complete responses to 325 abbreviated new drug applications (ANDAs) and approved or tentatively approved 101 ANDAs, the highest numbers in a single month since the enactment of Generic Drug User Fee Amendments (GDUFA).

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: ANDAs, GDUFA II, Complete Responses

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

Gottlieb: 'End the Shenanigans' on Delaying Generic Drug Competition By Zachary Brennan - Published 08 November 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday called to "end the shenanigans" that often delay or restrict generic drug competition.

Categories: News, US, FDA, FTC, Generic drugs, Government affairs, Reimbursement

Tags: generic drug competition, REMS, shared REMS, pay-for-delay

FDA Revises Priority ANDA Draft Guidance By Michael Mezher - Published 03 November 2017

The US Food and Drug Administration (FDA) on Friday issued a revised version of its draft guidance on the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA).

Categories: News, US, FDA, Generic drugs, Manufacturing, Submission and registration

Tags: Priority ANDAs, GDUFA II, Pre-Submission Facility Correspondence, PFC

Formal Dispute Resolution: FDA Finalizes Guidance By Michael Mezher - Published 03 November 2017

The US Food and Drug Administration (FDA) on Friday finalized its guidance on the system for formally disputing scientific or medical issues between a sponsor and the agency.

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Prescription drugs

Tags: Formal Dispute Resolution, FDR, FDRR

FDA Drafts Guidance on Controlled Correspondence Under GDUFA II By Zachary Brennan - Published 02 November 2017

The US Food and Drug Administration (FDA) on Thursday released draft guidance on the agency’s new commitments related to controlled correspondence under the recently reauthorized Generic Drug User Fee Amendments (GDUFA II).

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

Tags: GDUFA II, controlled correspondence, generic drug correspondence

FDA Describes New GDUFA II User Fee Structure By Michael Mezher - Published 27 October 2017

The US Food and Drug Administration (FDA) on Friday issued a draft guidance describing the new fee structure and types of fees applicable to generic drugmakers under the recently reauthorized Generic Drug User Fee Amendments (GDUFA II).

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Submission and registration

Tags: User Fees, GDUFA II

Meeting With FDA After a CRL: Draft Guidance on What to Expect By Zachary Brennan - Published 13 October 2017

The US Food and Drug Administration (FDA) on Friday released new draft guidance for industry on the 30-minute post-complete response letter (CRL) meetings between FDA and abbreviated new drug application (ANDA) applicants to help clarify deficiencies.

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

Tags: CRL, complete response letter, draft guidance

When to Submit an ANDA vs. a 505(b)(2) Application: FDA Discusses in Draft Guidance By Zachary Brennan - Published 12 October 2017

The US Food and Drug Administration (FDA) offers multiple abbreviated approval pathways for potential drug developers, and in new draft guidance released on Thursday the agency explains both the pathways where abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted.

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

Tags: 505(b)(2) application, ANDA, FDA draft guidance

Status Updates for ANDAs: FDA Spells Out GDUFA II Provision By Zachary Brennan - Published 06 October 2017

Under the second iteration of the Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) has agreed to provide timely abbreviated new drug application (ANDA) review status updates for all pending ANDAs.

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

Tags: GDUFA II, ANDA status updates

FDA Launches New Online Portal for Requesting Pre-ANDA Meetings By Zachary Brennan - Published 05 October 2017

Thanks to the new Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) this week launched a new online platform to allow industry to request pre-ANDA (abbreviated new drug application) meetings for complex generic drugs. 

Categories: News, US, CDER, Generic drugs

Tags: pre-ANDA meetings, FDA Direct NextGen Collaboration Portal

Another Record Year for US Generic Drug Approvals in 2017 By Zachary Brennan - Published 05 October 2017

The US Food and Drug Administration (FDA) has approved more abbreviated new drug application (ANDA) in 2017 than any other year, according to the latest FY 2017 activities report.

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

Tags: generic drug approvals, GDUFA, 2017 generic drug approvals

FDA Targets Complex Generic Drugs With New Draft Guidance By Zachary Brennan - Published 02 October 2017

The US Food and Drug Administration (FDA) on Monday kicked off a two-day meeting on modernizing generic drug development and released two new draft guidance documents on complex generic drugs – an area where increasing competition can be difficult.

Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Submission and registration

Tags: generic drugs, complex generic drugs, FDA draft guidance

Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable' By Zachary Brennan - Published 22 September 2017

A generic drug industry group and several companies have taken issue with recent US Food and Drug Administration (FDA) draft guidance on pre-submission facility correspondence (PFC) that spells out what companies need to do to obtain faster reviews for generic drugs.

Categories: News, US, FDA, Generic drugs, Government affairs, Manufacturing

Tags: Pre-submission facility guidance, FDA draft guidance, priority generic drug reviews

Balancing Hatch-Waxman: Stakeholders Weigh in After FDA’s Meeting By Zachary Brennan - Published 20 September 2017

Following a US Food and Drug Administration (FDA) meeting in July on generic drug competition, various stakeholders are offering written comments on reforms FDA and Congress could make to ensure the Hatch-Waxman amendments are not abused.

Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: REMS, Hatch-Waxman, generic drug competition

Health Technology Assessment, Reimbursement, Scientific Research, Risk Management, Generic Drug Legislation and a Preview of September By Gloria Hall - Published 06 September 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in September.

Categories: Features, FDA, Health Canada, Biologics and biotechnology, Generic drugs, Medical Devices, Regulatory strategy, Reimbursement

Tags: Regulatory Focus, Feature Articles, Editorial

FDA Aligns With Citizen Petition, Revises Draft Guidance on Pricey Generic Heart Drug By Zachary Brennan - Published 29 August 2017

Manufacturers looking to market generic versions of a heart medicine that has been around since the 18th century and seen its price rise by more than 600% in recent years will have to work with a new revised US Food and Drug Administration (FDA) draft guidance released Tuesday.

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

Tags: digoxin, generic draft guidance, Concordia Pharmaceuticals

FDA to Revise Pre-Submission Draft Guidance Due to GDUFA II By Zachary Brennan - Published 22 August 2017

Now that the FDA Reauthorization Act of 2017 (FDARA) is law, the US Food and Drug Administration (FDA) said Tuesday it will revise previously issued draft guidance on the pre-submission of certain information for abbreviated new drug applications (ANDAs).

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

Tags: FDARA, GDUFA, pre-submission guidance

Bioequivalence Studies of Solid Oral Dosage Forms Overview By Sharry Arora - Published 16 August 2017

The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US.

Categories: Features, EMA, FDA, Health Canada, MHLW, PMDA, TGA, WHO, Generic drugs

Tags: Bioequivalence, BE Studies, Solid Oral Dosage Forms, Bioavailability

Generic Drugs in 2017: FDA on Track for Most Approvals Ever By Zachary Brennan - Published 08 August 2017

Ten months into Fiscal Year 2017 and the US Food and Drug Administration (FDA) is on pace to break its record-setting year for abbreviated new drug application (ANDA) approvals from the last year.

Categories: News, US, FDA, Generic drugs, Government affairs, Submission and registration

Tags: generic drug approvals, ANDA approvals

FDA Finalizes 46 Bioequivalence Guidances By Michael Mezher - Published 04 August 2017

In its continued push to support the development of generic drugs, the US Food and Drug Administration (FDA) on Friday finalized 46 product-specific bioequivalence guidances.

Categories: News, FDA, Generic drugs

Tags: Bioequivalence Guidance, BE

Report Highlights Cracks in the Market for Generic Competition By Michael Mezher - Published 02 August 2017

As the US Food and Drug Administration (FDA) looks for ways to boost generic competition, a new working paper published by the National Bureau of Economic Research (NBER) suggests that competition among generic drugmakers slows over time, potentially leading to higher prices for older treatments and drug shortages.

Categories: News, US, FDA, Generic drugs

Tags: Generic Competition, National Bureau of Economic Research

FDA Finalizes GDUFA Q&A Guidance By Michael Mezher - Published 25 July 2017

The US Food and Drug Administration (FDA) on Tuesday finalized the second part of its question and answers guidance on issues related to the Generic Drug User Fee Amendments (GDUFA), including self-identification requirements, generic drug reviews, and inspections and compliance issues.

Categories: News, US, FDA, Compliance, Generic drugs, Submission and registration

Tags: Guidance, GDUFA, Abbreviated New Drug Application, Self-Identification

Gottlieb: FDA to Issue new Policies to Streamline Generic Reviews in 2017 By Michael Mezher - Published 18 July 2017

By the end of 2017, the US Food and Drug Administration (FDA) will issue two new documents to improve the review process for generic drugs, according to FDA Commissioner Scott Gottlieb.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: ANDAs, MAPP

FDA Publishes 21 New, 13 Revised Draft Generic Drug Guidances Published 13 July 2017

The US Food and Drug Administration (FDA) on Thursday published the 21 new and 13 revised draft guidance documents to help generic drugmakers conduct bioequivalence studies.

Categories: News, US, FDA, Generic drugs, Research and development

Tags: bioequivalence guidance, FDA draft guidance