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Filtering on: "topics drugs generic drugs"

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FDA Draft Guidance Looks to Help Speed New Generics to Market By Zachary Brennan - Published 13 January 2017

The blitz of new US Food and Drug Administration (FDA) guidance (11 draft and final documents in the last three days) continued on Friday with the release of a draft helping to clarify for generic drug companies how to define and use several terms, and new ways to expedite generic approvals.

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

Tags: RLD, generic drugs, ANDA, ANDA submission

180-Day Exclusivity for Generics: FDA Releases Draft Guidance By Zachary Brennan - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday put out new draft guidance consisting of 45 questions and answers on the 180 days of exclusivity provided to some generic drugs.

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

Tags: 180-day exclusivity, generic drugs, FDA guidance

CDER Guidance in 2017: Lots of Procedural and Quality Documents Coming By Zachary Brennan - Published 11 January 2017

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released its agenda of new and revised draft guidance documents to be published this calendar year, and it includes several eagerly-awaited documents, such as ones on biosimilar interchangeability (which has been on the list since 2015) and a revision of a draft on postmarket safety reporting for drugs and biologics.

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

Tags: interchangeability, FDA guidance, guidance agenda, CDER guidance

International Generic Drug Regulators Outline Plans for Collaboration Through 2020 By Zachary Brennan - Published 09 January 2017

As further cross-border harmonization among pharmaceutical regulators takes shape, the International Generic Drug Regulators Programme (IGDRP) has laid out its priorities that will take the group through the next four years.

Categories: News, Africa, Asia, Canada, Europe, US, Anvisa, CFDA, EC, EMA, FDA, Health Canada, ICH, Medsafe, MHLW, PMDA, TGA, WHO, Generic drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: generic drug regulation, COFEPRIS, DMFs, ASMFs

FDA Revises Refuse-to-Receive Guidance for ANDAs By Zachary Brennan - Published 21 December 2016

The second revision of the guidance, unveiled Wednesday, is part of the US Food and Drug Administration’s (FDA) attempt to assist abbreviated new drug application (ANDA) sponsors in understanding what deficiencies may cause FDA to refuse to receive (RTR) an ANDA.

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

Tags: ANDA, refuse-to-receive an ANDA, GDUFA, generic drugs

Complex Medicinal Products - the Other 'Biosimilar' By Douglas W. Balogh, PhD - Published 21 December 2016

This article discusses Non-Biological Complex Drugs (NBCDs) and how FDA and other regulatory agencies review and approve generic forms of these products.

Categories: Features, US, FDA, Generic drugs, Regulatory strategy, Submission and registration

Tags: Non-Biological Complex Drugs, NBCD

EU Pharma Patent Settlements Still Limiting Entry of Generics By Zachary Brennan - Published 13 December 2016

Almost three-quarters of 125 patent settlements in the EU between originator pharmaceutical and their generic competitors resulted in a lengthening of time to bring the cheaper generic version to market.

Categories: News, Europe, EC, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical patents, patent settlements with generic drugs

FDA Finalizes Guidance on Labeling By Michael Mezher - Published 02 December 2016

The US Food and Drug Administration (FDA) on Friday finalized its guidance for completing the clinical pharmacology section for drug, generic drug and biologic labels.

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

Tags: Clinical pharmacology

Mylan CEO Defends EpiPen Price Increases By Zachary Brennan - Published 01 December 2016

Mylan CEO Heather Bresch on Thursday defended the more than 400% price increase for its life-saving EpiPen, saying the company has made the device “more ergonomic” and that patients “never see the needle.”

Categories: News, US, Business and Leadership, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: EpiPen, Mylan, Heather Bresch, generic drug price gouging

FDA Declines PhRMA Changes, Offers Final Rule on Citizen Petitions Delaying Generic Approvals By Zachary Brennan - Published 08 November 2016

The US Food and Drug Administration (FDA) on Tuesday announced a final rule amending regulations on citizen petitions that would ensure the agency does not delay the approval of a pending generic drug or biosimilar because of such petitions, unless that delay is necessary to protect the public health.

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

Tags: PhRMA, citizen petitions, generic drug approvals

Asia Regulatory Roundup: CFDA Begins Verifying Trial Data (8 November 2016) By Nick Paul Taylor - Published 08 November 2016

China's Food and Drug Administration (CFDA) has verified data generated in clinical trials sponsored by AstraZeneca, Johnson & Johnson and Sanofi among the first batch of 55 clinical trials to be verified by the regulator under its data audit initiative.

Categories: News, China, Oceania, CFDA, TGA, Biologics and biotechnology, Generic drugs, Medical Devices, Nutritional and dietary supplements, Submission and registration

Tags: Asia Regulatory Roundup, Regulatory Roundup

Generic Drug Backlog at FDA: A Dive Into the Confusing Numbers By Zachary Brennan - Published 01 November 2016

As the debate over skyrocketing drug prices continues, at least one solution has cropped up in nearly every conversation: Reduce the generic drug backlog at the US Food and Drug Administration (FDA), create more competition and drug prices will come down.

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

Tags: generic drug approvals, drug prices, high drug prices, ANDA approvals, generic drug backlog, FDA backlog

GDUFA Science Priorities for 2017: Postmarket Evaluation and Complex Generics By Zachary Brennan - Published 27 October 2016

In the final year of the first Generic Drug User Fee Act (GDUFA I), FDA’s Office of Generic Drugs (OGD) is planning to prioritize the post-market evaluation of generics, work on the equivalence of complex generics and locally acting products, as well as new standards and computational and analytical tools.

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

Tags: GDUFA, generic drugs, FDA science priorities

MHRA Lifts Suspension on Teva Thyroid Drug By Michael Mezher - Published 19 October 2016

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday announced it has lifted its suspension of Israeli drugmaker Teva Pharmaceuticals' levothyroxine tablets used to treat hypothyroidism.

Categories: News, Europe, MHRA, Generic drugs, Manufacturing, Submission and registration

Tags: levothyroxine, Teva

FDA Proposes to Withdraw Two Generic Versions of ADHD Drug Concerta By Zachary Brennan - Published 18 October 2016

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday proposed withdrawing two generic versions of Janssen’s extended-release attention deficit hyperactive disorder (ADHD) drug Concerta (methylphenidate hydrochloride) two years after determining that they do not provide sufficient therapeutic effects.

Categories: News, US, CDER, Crisis management, Generic drugs, Due Diligence, Government affairs

Tags: Mallinckrodt, Lannett Company, FAERS, generic drug approval, extended-release generic drugs

Updated: GDUFA II Performance Goals: 8-Month Priority Reviews, More Timely Correspondence By Zachary Brennan - Published 17 October 2016

The US Food and Drug Administration (FDA) will speed the review of abbreviated new drug applications (ANDAs) and work with generic drugmakers on a closer and more timely basis, according to the draft performance goals and program enhancements for the Generic Drug User Fee Act (GDUFA) reauthorization for FYs 2018-2022, known as GDUFA II.  

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

Tags: GDUFA II, generic drugs, generic drugs performance goals

FY 2016 Generic Approvals by FDA: A New Record Under GDUFA By Zachary Brennan - Published 12 October 2016

The US Food and Drug Administration (FDA) published final Fiscal Year 2016 abbreviated new drug application (ANDA) approvals earlier this month, revealing 651 approvals (though it’s 835 if tentative approvals are included), which was 159 more than the number of approvals for FY 2015 and 242 more than the agency approved in FY 2014.

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

Tags: OGD, ANDA approvals, FDA approvals of generic drugs

GDUFA II: FDA Looks to Speed Up Generic Drug Approval Process By Zachary Brennan - Published 26 September 2016

On 21 October, the US Food and Drug Administration (FDA) will meet to discuss plans for the second iteration of the Generic Drug User Fee Act (GDUFA II) under which FDA says it will begin offering eight-month and 10-month reviews of abbreviated new drug applications (ANDAs) between 2018 and 2022.

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

Tags: ANDA backlog, generic drug reviews, generic competition

FDA Finalizes Guidance on Generic Drug Facility Self-Identification By Zachary Brennan - Published 22 September 2016

The US Food and Drug Administration (FDA) on Thursday finalized guidance on information regarding what companies need to self-identify as a producer of generic drugs and what information they must provide to FDA.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Government affairs, Manufacturing

Tags: GDUFA, generic facility self-identification, FDA guidance

GAO Report: 315 Generics More Than Doubled in Price Since 2010 By Michael Mezher - Published 13 September 2016

A new report by the US Government Accountability Office (GAO) found that the price for generic drugs under Medicare Part D fell significantly since 2010 despite some "extraordinary" increases for 315 generics.

Categories: News, US, Generic drugs, Reimbursement

Authorized Generics: Why Mylan Would Compete With Itself in the EpiPen Market By Zachary Brennan - Published 29 August 2016

As part of an attempt to quell the furor over its more than 400% price increase for its life-saving EpiPen, Mylan announced on Monday that it would soon launch an authorized generic version of its autoinjector for half the price of the brand-name product.

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

Tags: Mylan, EpiPen, generic competition, authorized generics

Impurity Deficiencies: How FDA Can Refuse-to-Receive an ANDA By Zachary Brennan - Published 24 August 2016

The US Food and Drug Administration (FDA) on Wednesday finalized guidance that will assist abbreviated new drug application (ANDA) submitters seeking approval for a new strength of a drug.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Quality, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: refuse-to-receive an ANDA, ANDA submission, generic drug submission

Drug Companies Reveal Shortcomings in FDA Draft Guidance on Generic Topical Patches By Zachary Brennan - Published 18 August 2016

Mylan, Perrigo, AstraZeneca and Apotex are seeking more clarity and raising questions with the shortcomings of US Food and Drug Administration (FDA) draft guidance that aims to improve the way adhesion data is treated for abbreviated new drug application (ANDA) submissions of transdermal delivery systems and topical patches.

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

Tags: Perrigo, Mylan, AstraZeneca, ANDAs for topical patches

FDA Offers First Major Update to ‘Orange Book’ Website By Zachary Brennan - Published 15 August 2016

The US Food and Drug Administration (FDA) on Monday launched an improved web-based version of its publication on drugs approved on the basis of safety and effectiveness, more commonly known as the “Orange Book.”

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

Tags: Orange Book, list of generic drugs from FDA, FDA list of drugs

Capsule Supplier Changes: FDA Offers an Updated Policy By Michael Mezher - Published 15 August 2016

Changing the supplier of gelatin capsules used to encase drugs constitutes a minor change, and does not require a prior approval supplement (PAS), according to a US Food and Drug Administration (FDA) policy that went into effect Monday.

Categories: News, US, FDA, Generic drugs, Prescription drugs, Manufacturing

Tags: Prior Approval Supplement, Gelatin Capsules, Supplier Change