AUTHOR OF THIS BLOG

DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER

Drug Patent expiry in 2017

 PATENTS  Comments Off on Drug Patent expiry in 2017
Jan 102017
 

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“ALL FOR DRUGS” CATERS TO EDUCATION GLOBALLY, No commercial exploits are done or advertisements added by me. This article is a compilation for educational purposes only.

P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent

///////////Drug Patent,  expiry, 2017

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QbD in Pharma Development World Congress 2017, SelectBio, 20-21 April, 2017, Radisson Hyderabad HITEC City, India

 CONFERENCE, QbD  Comments Off on QbD in Pharma Development World Congress 2017, SelectBio, 20-21 April, 2017, Radisson Hyderabad HITEC City, India
Oct 212016
 

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http://selectbiosciences.com/images/DEL_QBD_20Oct.html

QbD in Pharma Development World Congress 2017 Registration

3 for 2 Offer

SELECTBIO are offering 3 for the price of 2 on all delegate passes. To take advantage of this offer contact us by email, phone or click the Contact Us button below. Looking for more than 3 passes? Contact us for more information on our special rates for large groups.

Radisson Hyderabad HITEC City

Radisson Hyderabad HITEC City

Flights

To find low cost flights, try the following websites:

Flightchecker
Travelsupermarket
Kayak

The refined Radisson Hyderabad Hitec City features the prompt services, such as a concierge, and comfortable, air-conditioned rooms you need for a satisfying visit. You can stay fit with laps in the swimming pool and fitness centre, or relax in your suite with 24-hour room service and free Wi-Fi access. The aminities include Satellite TV, Work desk, Wi-Fi access, Tea and coffeemaker, Bottles of mineral water, Large bathrooms with separate rain showers, Large wardrobe, Mini barWrap up a day of meetings with authentic Indian cuisine at Cascade or exotic Asian specialties at The Oriental Blossom. Treat your colleagues to drinks at Zyng lounge bar, or if the weather is nice, gather outside at Poolside Grill for a barbecued meal.
A business centre is also available to help you complete work while staying at this Hitec City hotel in the heart of Gachibowli, a new-age IT suburb of Hyderabad, near the Hyderabad International Convention Centre.
SELECTBIO has negotiated special rates (see below) to include buffet breakfast, and Wi-Fi. Standard Room Single/Double – INR 4500/5000+Tax
To make your reservation at these discounted rates please contact Sakshi Modgil at s.modgil@selectbio.com. We recommend early booking to avoid disappointment.

Sakshi Modgil's Profile PhotoSAKSHI MODGIL

Visa Requirements
International visitors travelling from outside India will require a Business visa.
PLEASE NOTE, THIS EVENT IS NOT ASSOCIATED WITH THE INDIAN GOVERNMENT, THEREFORE CONFERENCE VISA IS NOT APPLICABLE
International visitors will require an invitation letter to obtain their Business visa. We will only provide invitation letters to customers that are fully registered for the event. In the event of an unsuccessful visa application we will refund the full delegate fee paid.
http://selectbiosciences.com/media/VISA_Invitation_Letter_Requirements.pdf

Visa Invitation Requirement
Please ensure that the above form is duly complete, as it will expedite the preparation of an invitation letter. Also mention clearly, to whom the invitation letter should be addressed as per the requirement of the country of origin.
For more information on Indian visa’s applications for International visitors, please contact your local Indian embassy.
Please plan sufficiently in advance because processing of Indian Visa Application may take 4-6 weeks.

Copyright © 2016 SELECTBIO, All rights reserved.

This email was sent from SELECTBIO Ltd to amcrasto@gmail.com.

SELECTBIO Ltd, Woodview, Bull Lane, Sudbury, CO10 0FD, United Kingdom.

//////////QbD,  Pharma Development,  World Congress,  2017, SelectBio, Radisson Hyderabad HITEC City, India

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FDA published generic user fee for 2017: for ANDA, DMF, and for Facility (API, FDF)

 regulatory  Comments Off on FDA published generic user fee for 2017: for ANDA, DMF, and for Facility (API, FDF)
Aug 032016
 

 

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http://www.raps.org/Regulatory-Focus/News/2016/07/26/25394/FDA-Lowers-ANDA-Fee-Rates-for-2017/

Generic drugmakers submitting abbreviated new drug applications (ANDAs) and prior approval supplements (PAS) will see their US Food and Drug Administration (FDA) fee rates drop in 2017, though all other rates, including those for drug master files (DMF) and facility fees will increase when compared to 2016.

For FY 2017, the generic drug fee rates are: ANDA ($70,480, down from $76,030 in 2016), PAS ($35,240, down from $38,020 in 2016), DMF ($51,140, up from $42,170 in 2016), domestic active pharmaceutical ingredient (API) facility ($44,234, up from $40,867 in 2016), foreign API facility ($59,234, up from $55,867 in 2016), domestic finished dose formulation (FDF) facility ($258,646, up from $243,905), and foreign FDF facility ($273,646, up from $258,905 in 2016).

The new fees are effective 1 October 2016 and will remain in effect through 30 September 2017.

FDA explained the increases and decreases in fees, noting that for ANDA and PAS fees, the agency is expecting an increase in the number of submissions estimated to be submitted in FY 2017 when compared to 2016. For 2017, the agency estimates that approximately 891 new original ANDAs and 439 PASs will be submitted and incur filing fees.

Fees for DMFs will increase, meanwhile, because of an expected decrease in the number of submissions estimated to be submitted in 2017 (FDA is estimating 379 fee-paying DMFs for 2017), when compared to the estimated submissions from 2016.

And all facility fees will increase in 2017 when compared to the previous year because of a decrease in the number of facilities that self-identified (the total number of FDF facilities identified through self-identification was 675, of which 255 were domestic facilities and 420 foreign facilities; while the total number of API facilities self-identified was 789, of which 101 were domestic facilities and 688 were foreign facilities), FDA said.

How FDA Calculates the Fees

In order to calculate the ANDA fee, FDA estimated the number of full application equivalents (FAEs) that will be submitted in FY 2017, which is done by assuming ANDAs count as one FAE and PASs (supplements) count as one-half of an FAE, since the fee for a PAS is one half of the fee for an ANDA.

The Generic Drug User Fee Act (GDUFA) also requires that 75% of the fee paid for an ANDA or PAS filing be refunded if either application is refused due to issues other than a failure to pay the fees.

And since this is the last year of this iteration of GDUFA (the next version is still in the works), the agency is allowed to further increase the fee revenues and fees established if such an adjustment is necessary to provide for not more than three months of operating reserves for the first three months of FY 2018, though FDA estimates that the GDUFA program will have carryover balances for such activities in excess of three months of such operating reserves, so FDA will not be performing a final year adjustment.

To pay the fees, companies must complete a Generic Drug User Fee Cover Sheet, available at http://www.fda.gov/gdufa and generate a user fee identification (ID) number. Payment must be made in US currency drawn on a US bank by electronic check, check, bank draft, US postal money order or wire transfer.

Federal Register Notice

See more at: http://www.raps.org/Regulatory-Focus/News/2016/07/26/25394/FDA-Lowers-ANDA-Fee-Rates-for-2017/#sthash.FNo99XHR.dpuf

 

 

/////////////FDA,  generic user fee,  2017, ANDA, DMF,  Facility, API, FDF

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