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On-Site Training Seminars

Includes: Books, Travel, Hotels and Expenses and Certificates

1-Day Drug GMP Boot Camp

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Whats New with CDER

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August 4, 2017

August 3, 2017

August 2, 2017

August 1, 2017

July 31, 2017

July 28, 2017


CDER Workshops, Meetings and Conferences

Upcoming

August 2017

  • Public Meetings: Enhanced Drug Distribution Security under the Drug Supply Chain Security Act, August 23, 2017, 9 am to 4 pm, FDA White Oak campus, 10903 New Hampshire Ave, Building 31, Great Room (Room 1503), Silver Spring, MD 20903.  Meeting information

September 2017

  • Reducing the Risk of Preventable Adverse Drug Events associated with Hypoglycemia in the Older Population, September 12, 2017, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993. Meeting information
  • Pediatric Trial Design and Modeling: Moving into the next decade. September 8, 2017. Food and Drug Administration, 10903 New Hampshire Ave. Building 31, Great Room, Silver Spring, MD 20993. Meeting Information
  • FDA-ASCO: Hematology and Oncology Fellows Day Workshop, September 15, 2017, FDA White Oak Campus, Building 22, Conference Room 2205, Silver Spring MD, 20993. Meeting information

October 2017

  • Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review; Public Workshop, October 2 - 3, 2017,  Silver Spring, MD 20993. Meeting information 
  • Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: Advances in Characterization and In Vitro Testing, October 6, 2017 from 8:00 a.m. to 4:00 p.m. at FDA’s White Oak campus 10903 New Hampshire Ave, Building 31 (The Great Room 1503B+C), Silver Spring, MD 20903-0002. Meeting information
  • Overcoming Barriers to Product Development, Regulatory Approval and Commercialization of Affordable, High Quality, Generic Topical Dermatological Drug Products; Public Workshop October 20, 2017 (8:30am – 4:30pm) FDA White Oak Campus, 10903 New Hampshire Avenue Bldg. 31, Room 1503 (Great Room) Silver Spring, Maryland 20993. Meeting information
  • CDER Rare Diseases Public Workshop: Strategies, Tools and Best Practices for Effective Advocacy in Rare Diseases Drug Development, October 30, 2017, FDA White Oak Campus, 10903 New Hampshire Avenue Bldg. 31, Room 1503 (Great Room) Silver Spring, Maryland 20993. Meeting information 

Whats New with FDA

Upcoming Events

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July 2017

June 2017


Whats New with CBER


CBER Workshops, Meetings and Conferences


Whats New with CDRH

August 4, 2017

August 3, 2017

August 2, 2017

August 1, 2017

July 31, 2017

July 28, 2017


CDRH Workshops, Meetings and Conferences

 


Recalls & Alerts


Weekly Rule Changes

Monday - NONE
Tuesday - NONE
Wednesday - NONE
Thursday - NONE
Friday - NONE

Friday, August 4, 2017

Food and Drug Administration

NONE

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Thursday, August 3, 2017

Food and Drug Administration

  Notices
  Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant
  Pages 36149 - 36150 [FR DOC # 2017-16380] PDF | Text
 
  Child-Resistant Packaging Statements in Drug Product Labeling; Draft Guidance for Industry; Availability
  Pages 36148 - 36149 [FR DOC # 2017-16379] PDF | Text
 
  B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application
  Pages 36150 - 36150 [FR DOC # 2017-16377] PDF | Text
 

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Wednesday, August 2, 2017

Food and Drug Administration

  Notices
  Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2018
  Pages 35954 - 35957 [FR DOC # 2017-16184] PDF | Text
 
  Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2018
  Pages 35957 - 35962 [FR DOC # 2017-16181] PDF | Text
 
  Outsourcing Facility Fee Rates for Fiscal Year 2018
  Pages 35962 - 35965 [FR DOC # 2017-16185] PDF | Text
 
  Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2018
  Pages 35966 - 35971 [FR DOC # 2017-16180] PDF | Text
 
  Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation)
  Pages 35971 - 35973 [FR DOC # 2017-16230] PDF | Text
 
  Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases; Guidance for Industry; Availability
  Pages 35973 - 35974 [FR DOC # 2017-16228] PDF | Text
 
  Over-the-Counter Monograph User Fees: Stakeholder Meeting
  Pages 35965 - 35966 [FR DOC # 2017-16229] PDF | Text
 

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Tuesday, August 1, 2017

Food and Drug Administration

NONE

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Monday, July 31, 2017

Food and Drug Administration

  Notices
  Cardiac Troponin Assays; Public Workshop; Request for Comments
  Pages 35532 - 35534 [FR DOC # 2017-16007] PDF | Text
 
  Developing a Framework for Regulatory Use of Real-World Evidence; Public Workshop
  Pages 35534 - 35535 [FR DOC # 2017-16021] PDF | Text
 

 

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On-Site Training Seminars

Includes: Books, Travel, Hotels and Expenses and Certificates

1-Day Drug GMP Boot Camp

1-Day Device GMP Boot Camp

2-Day Drug GMP Boot Camp

2-Day Device GMP Boot Camp

3-Day Master GMP Boot Camp

3-Day Audit & 2 Day GMP Training

1-Day Part 11 / Validation
 
 
 
 
 
 
 
 
 
 
 




The Week's Drug Approvals

August 4, 2017

Drug Name and
Application Number
Dosage Form/ Route Company Submission Classification
Altoprev
NDA #021316
Tablet, Extended Release; Oral Covis Pharma Bv Labeling
Crestor
NDA #021366
Tablet; Oral Ipr Labeling
Lescol
NDA #020261
Capsule; Oral Novartis Labeling
Lescol Xl
NDA #021192
Tablet, Extended Release; Oral Novartis Labeling
Liptruzet
NDA #200153
Tablet; Oral Merck Sharp Dohme Labeling
Liquid E-Z-Paque
NDA #208143
Suspension; Oral Bracco Efficacy
Readi-Cat 2
NDA #208143
Suspension; Oral Bracco Efficacy
Readi-Cat 2 Smoothies
NDA #208143
Suspension; Oral Bracco Efficacy

August 3, 2017

Drug Name and
Application Number
Dosage Form/ Route Company Submission Classification
Gemcitabine
NDA #209604
Injectable; Injection Accord Hlthcare Inc Type 5 - New Formulation or New Manufacturer
Liletta
NDA #206229
Intrauterine Device; Intrauterine Medicines360 Efficacy
Lotensin Hct
NDA #020033
Tablet; Oral Us Pharms Holdings I Labeling
Lotensin
NDA #019851
Tablet; Oral Us Pharms Holdings I Labeling
Nevirapine
ANDA #207684
Suspension; Oral Cipla Ltd
Qvar
NDA #207921
Aerosol; Oral Norton Waterford Ltd
Velphoro
NDA #205109
Tablet, Chewable; Oral Vifor Fresenius Labeling
Vyxeos
NDA #209401
Injectable, Liposomal; Injection Celator Pharma Inc Type 3 - New Dosage Form

August 2, 2017

Drug Name and
Application Number
Dosage Form/ Route Company Submission Classification
Adapalene and Benzoyl Peroxide
ANDA #209148
Gel; Topical Takeda Pharms Usa
Dolutegravir;Lamivudine;Tenofovir Disoproxil Fumarate
NDA #209670
Tablet; Oral Mylan Pharms Inc Type 4 - New Combination
Imbruvica
NDA #205552
Capsule; Oral Pharmacyclics Inc Efficacy
Isoproterenol Hydrochloride
ANDA #206961
Injectable; Injection Nexus Pharms
Juxtapid
NDA #203858
Capsule; Oral Aegerion Labeling
Mavik
NDA #020528
Tablet; Oral Abbvie Labeling
Staxyn
NDA #200179
Tablet, Orally Disintegrating; Oral Bayer Hlthcare Efficacy
Tarka
NDA #020591
Tablet, Extended Release; Oral Abbvie Labeling

August 1, 2017

Drug Name and
Application Number
Dosage Form/ Route Company Submission Classification
Amitiza
NDA #021908
Capsule; Oral Sucampo Pharma Llc Labeling
Capoten
NDA #018343
Tablet; Oral Par Pharm Labeling
Epclusa
NDA #208341
Tablet; Oral Gilead Sciences Inc Efficacy
Erivedge
NDA #203388
Capsule; Oral Genentech Labeling
Idhifa
NDA #209606
Tablet; Oral Celgene Corp Type 1 - New Molecular Entity
Movantik
NDA #204760
Tablet; Oral Astrazeneca Pharms Labeling
Movantik
NDA #204760
Tablet; Oral Astrazeneca Pharms Labeling
Relistor
NDA #021964
Solution; Subcutaneous Salix Pharms Labeling
Relistor
NDA #021964
Solution; Subcutaneous Salix Pharms Labeling
Relistor
NDA #208271
Tablet; Oral Salix Pharms Inc Labeling
Symproic
NDA #208854
Tablet; Oral Shionogi Inc Labeling
Symproic
NDA #208854
Tablet; Oral Shionogi Inc Labeling
Tanzeum
BLA #125431
Injectable; Injection Glaxosmithkline Llc Labeling
Tanzeum
BLA #125431
Injectable; Injection Glaxosmithkline Llc Labeling
Trulicity
BLA #125469
Injectable; Injection Eli Lilly and Co Labeling
Trulicity
BLA #125469
Injectable; Injection Eli Lilly and Co Labeling

July 31, 2017

Drug Name and
Application Number
Dosage Form/ Route Company Submission Classification
Acyclovir
ANDA #205510
Ointment; Topical Glenmark Pharms Ltd
Acyclovir
ANDA #206437
Ointment; Topical Tolmar
Brimonidine
ANDA #209158
Gel; Topical Perrigo Uk Finco
Budesonide
ANDA #206200
Capsule; Oral Amneal Pharms
Clobetasol Propionate
ANDA #206805
Aerosol, Foam; Topical Ingenus Pharms Llc
Clonazepam
ANDA #074979
Tablet; Oral Sandoz Labeling
Clonazepam
ANDA #074979
Tablet; Oral Sandoz Labeling
Daptomycin
ANDA #202857
Powder; Intravenous Hospira Inc Labeling
Daptomycin
ANDA #202857
Powder; Intravenous Hospira Inc Labeling
Fluocinonide
ANDA #207538
Ointment; Topical Novel Labs Inc
H.P. Acthar Gel
NDA #008372
Injectable; Injection Mallinckrodt Ard Labeling
Ibuprofen
ANDA #070985
Tablet; Oral Merro Pharm Labeling
Kalydeco
NDA #203188
Tablet; Oral Vertex Pharms Efficacy
Kalydeco
NDA #207925
Granule; Oral Vertex Pharms Inc Efficacy
Lenvima
NDA #206947
Capsule; Oral Eisai Inc Labeling
Mafenide Acetate
ANDA #206716
For Solution; Topical Riconpharma Llc
Methocarbamol
ANDA #207522
Solution; Im-Iv Somerset Theraps Llc
Nevirapine
ANDA #207467
Tablet, Extended Release; Oral Sciegen Pharms Inc
Ondansetron Hydrochloride
ANDA #204906
Injectable; Injection Mylan Labs Ltd
Opdivo
BLA #125554
Injectable; Injection Bristol Myers Squibb Efficacy
Oxacillin Sodium
ANDA #207147
Injectable; Injection Wockhardt Bio Ag
Revatio
NDA #021845
Tablet; Oral Pfizer Labeling
Revatio
NDA #022473
Solution; Intravenous Pfizer Labeling
Revatio
NDA #203109
For Suspension; Oral Pfizer Labeling
Rosuvastatin Calcium
ANDA #205587
Tablet; Oral Lupin Ltd
Temozolomide
ANDA #206750
Capsule; Oral Zydus Pharms Usa Inc
Vyvanse
NDA #021977
Capsule; Oral Shire Development Labeling
Vyvanse
NDA #208510
Tablet, Chewable; Oral Shire Dev Llc Labeling

July 29, 2017

Drug Name and
Application Number
Dosage Form/ Route Company Submission Classification
Latisse
NDA #022369
Solution/Drops; Topical Allergan Labeling
Lumigan
NDA #021275
Solution/Drops; Ophthalmic Allergan Labeling
Lumigan
NDA #022184
Solution/Drops; Ophthalmic Allergan Labeling