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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FDA Aligns With Citizen Petition, Revises Draft Guidance on Pricey Generic Heart Drug By Zachary Brennan - Published 29 August 2017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price rise by more than 600% in recent years will have to work with a new revised US Food and Drug Administration (FDA) draft guidance released Tuesday.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Tags: digoxin, generic draft guidance, Concordia Pharmaceuticals

FDA to Revise Pre-Submission Draft Guidance Due to GDUFA II By Zachary Brennan - Published 22 August 2017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Act of 2017 (FDARA) is law, the US Food and Drug Administration (FDA) said Tuesday it will revise previously issued draft guidance on the pre-submission of certain information for abbreviated new drug applications (ANDAs).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

FDA Speeding Generic Drug Approvals: Not Just Lip Service By Zachary Brennan - Published 10 July 2017

May and June 2017 have seen the most generic drug approvals since the US Food and Drug Administration (FDA) began tallying its monthly approvals, lending credence to FDA Commissioner Scott Gottlieb's pledge to speed approvals and lower drug costs.

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

Tags: FDA generic drug approvals, GDUFA, ANDA approvals

Generic Industry Group Sues Maryland Over Price Gouging Law By Zachary Brennan - Published 06 July 2017

The Association for Accessible Medicines (AAM), a trade group representing US manufacturers of generic drugs and biosimilars, on Thursday sued Maryland over a new law that will impose fines on generic drugmakers if prices rise by too much or too quickly.

Categories: News, US, Business and Leadership, Generic drugs, Government affairs

Tags: AAM, generic drugs, Maryland drug price gouging law

GAO: FDA Needs a Plan for GDUFA Carryover Fees By Michael Mezher - Published 27 June 2017

As Congress looks to reauthorize the US Food and Drug Administration's (FDA) user fee programs, the Government Accountability Office (GAO) on Monday released a report saying that FDA should develop a plan for managing unspent fees collected from generic drugmakers.

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

Tags: GDUFA, User Fees, Carryover, Government Accountability Office, GAO

FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition By Zachary Brennan - Published 27 June 2017

The US Food and Drug Administration (FDA) took major steps toward increasing generic drug competition on Tuesday by releasing a list of off-patent pharmaceuticals with limited or no competition, and by prioritizing the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug.

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

Tags: generic drugs, priority review of generics, drug price competition, drug prices

Senators Ask FDA Commissioner What Help He Needs to Tackle REMS Abuse By Michael Mezher - Published 26 June 2017

In a letter sent to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb last week, a bipartisan group of senators say they want to know what FDA can and cannot do to address certain tactics used to delay generic drug competition.

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

Tags: REMS, Generic Competition

Gottlieb Looks to Boost Generic Drug Competition By Michael Mezher - Published 21 June 2017

As the US continues to grapple with the high cost of prescription drugs, the Food and Drug Administration (FDA) on Wednesday announced plans to stop drugmakers from gaming the system to block generic competition.

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

Tags: REMS, Competition, Generic Drugs

FDA Commissioner Vows to Eliminate Backlog of Orphan Drug Designation Requests By Michael Mezher - Published 20 June 2017

At a Senate hearing on President Donald Trump's FY2018 budget request for the US Food and Drug Administration (FDA), Commissioner Scott Gottlieb vowed to eliminate the backlog of orphan drug designation requests and said he will soon release "modern and risk-based" tools for assessing new treatments, especially for rare diseases and conditions with no effective treatments.

Categories: News, US, FDA, Generic drugs, Orphan products

Tags: FY2018 Budget, Appropriations, Orphan Drug Designations, REMS, Scott Gottlieb

Priority Generic Drug Reviews: New FDA Draft Guidance By Michael Mezher - Published 19 June 2017

In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II), the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs.

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

Tags: Priority Generics, ANDA, Pre-Submission Facility Correspondence, PFC

US FDA Sees Major Spike in BA/BE Studies in India By Zachary Brennan - Published 19 June 2017

In 2002, the US Food and Drug Administration (FDA) did not conduct any bioavailability (BA) or bioequivalence (BE) study inspections in India for generic drug applications. A little more than a decade later, and nearly half of all FDA's BA/BE study inspections are conducted on the subcontinent.

Categories: News, India, US, CDSCO, FDA, Clinical, Crisis management, Generic drugs, Government affairs

Tags: BA and BE studies, bioequivalence, generic drugs from India

CBO Releases Cost Estimate for User Fee Bill By Michael Mezher - Published 19 June 2017

The Congressional Budget Office (CBO) on Thursday released its cost estimate for the Senate's bill to reauthorize the US Food and Drug Administration's (FDA) user fee programs, saying the agency will need $1.2 billion in appropriations from 2018-2022 to implement changes brought on by the bill.

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Prescription drugs, Government affairs, Medical Devices, Submission and registration

Tags: CBO, User Fees, Reauthorization

FDA Offers Updated Form for Field Alert Reports By Michael Mezher - Published 16 June 2017

The US Food and Drug Administration (FDA) on Thursday released an updated version of its automated Field Alert Report (FAR) form, following the conclusion of a successful four-year pilot program.

Categories: News, US, FDA, Generic drugs, Prescription drugs, Postmarket surveillance

Tags: FAR, Field Alert Reports

FDA Approves First Generic Version of Gilead's HIV Drug Truvada By Michael Mezher - Published 09 June 2017

The US Food and Drug Administration (FDA) on Friday announced it has approved Teva Pharmaceuticals' generic version of Gilead's HIV drug Truvada (emtricitabine and tenofovir disoproxil fumarate).

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

Tags: Truvada, Teva, Gilead, PrEP

New Maryland Law to Restrict Generic Drug Price Increases By Zachary Brennan - Published 30 May 2017

A new Maryland law to keep generic drug prices from increasing by too much goes a step further than price transparency bills and laws in other states, but it’s leaving some with more questions about its broader impact.

Categories: News, US, Biologics and biotechnology, Business Skills, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug prices, state drug price legislation, drug price increases, Nevada insulin

Copaxone Generics: Who Will Win First Filer Exclusivity? By Zachary Brennan - Published 25 May 2017

Generic versions of Teva’s multi-billion-dollar per year multiple sclerosis drug Copaxone (glatiramer) are coming, but a closer look at which competitor might win the coveted 180-day exclusivity for its generic reveals an unusual and complex situation.

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

Tags: Copaxone, Teva, Mylan, Momenta, Synthon, Dr. Reddy's