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- NDA
- nondisclosure agreement or nondisparagement agreement
- NDA definition on BNET »
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- Non-Disclosure Of Trade Secrets
- A Non-Disclosure Agreement NDA is a legal contract between at least two parties that outlines confidential materials or knowledge the parties wish to share with one another for certain purposes, but wish to restrict from generalized use. In other words, it is a contract through which the parties agree not...
- Tools & templates 2007-12-01
- A General Non-Disclosure Agreement For A Specific Project
- A Non-Disclosure Agreement NDA is a legal contract between at least two parties that outlines confidential materials or knowledge the parties wish to share with one another for certain purposes, but wish to restrict from generalized use. In other words, it is a contract through which the parties agree not...
- Tools & templates 2007-12-01
- Santarus Inc. Q1 2008 Earnings Call Transcript
- Question-and-Answer SessionOperator Operator instructions One moment, please, for the first question. Gerry Proehl While we are waiting for questions, we would like to inform you that we will be presenting at the Friedman, Billings, Ramsey Capital Markets Annual Spring Investor Conference on May 28th at 8:15 a.m., at the...
- Earnings calls 2008-05-27
- BioForm Medical, Inc. F1Q09 (Qtr End 09/30/08) Earnings Call Transcript
- Question-and-Answer Session Operator Operator Instructions. Our first question comes from Tom Gunderson with Piper Jaffray. Tom Gunderson - Piper Jaffray Tough times out there but necessary moves that you're making. Two questions. One, I know, it’ll sound a little too philosophical, but I’d still like to hear your answer...
- Earnings calls 2008-11-06
- Biodel Inc. F3Q09 (Qtr End 06/30/09) Earnings Call Transcript
- Question-and-Answer SessionOperator Operator Instructions. We’ll take our first question from Corey Davis with Natixis. Corey Davis - Natixis Sol, it’s unclear to me from the two studies that you mentioned specifically, the bridging study in the Type 1 pilot, it sounds like those are going to be part of...
- Earnings calls 2009-08-07
Additional Resources
- FDA Approves NDA for ^sup 13^N-Ammonia Injection
- On August 23, the U.S. Food and Drug Administration FDA approved a new drug application NDA for a ^sup 13^N-ammonia injection product, under the title "Ammonia N 13 Injection." The approved NDA reference number is NDA 22-119. Thomas Chaly, POn August 23, the U.S. Food and Drug Administration FDA approved...
- Research articles 2007-10-01
- New ^sup 18^F-FDG NDA
- On August 19, the Food and Drug Administration FDA approved a new drug application NDA for an ^sup 18^F-FDG injection. The NDA was submitted by Dr. Thomas Chaly from North Shore/LIJ Research Institute at the New York University Medical College (ManhasOn August 19, the Food and Drug Administration FDA approved...
- Research articles 2005-10-01
- Titan Reports FDA Acceptance of Iloperidone NDA
- SOUTH SAN FRANCISCO, Calif. -- Titan Pharmaceuticals, Inc. (AMEX: TTP) announced that the U.S. Food and Drug Administration FDA officially accepted a New Drug Application NDA submitted for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia. The NDA was submitted by Vanda Pharmaceuticals Inc. (NASDAQ: VNDA). The NDA...
- Research articles 2007-11-28
- FDA Accepts for Review NDA Filing and Grants Priority Review for Velcade (Bortezomib) for Injection
- In this article Millennium Pharmaceuticals, Inc. reveals that the U.S. Food and Drug Administration FDA accepted for review and granted Priority Review designation of the Company's New Drug Application NDA for VELCADE for the treatment of relapsed and refractory multiple myeloma. Priority Review is granted by the FDA to an...
- White papers 2003-03-10
- Theravance Announces FDA Acceptance of Telavancin NDA
- Theravance, Inc. (NASDAQ: THRX) announced today that the U.S. Food & Drug Administration FDA has accepted the New Drug Application NDA for its investigational antibiotic telavancin for the treatment of complicated skin and skin structure infections cSSSI caused by Gram-positive organisms, including methicillin-resistant Staphylococcus aureus MRSA. The FDA has...
- Research articles 2007-02-20
- FDA Accepts DOR BioPharma's NDA Filing for orBec(R)
- DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company") announced today that the U.S. Food and Drug Administration ("FDA") has accepted the Company's New Drug Application ("NDA") for orBec® oral beclomethasone dipropionate for the treatment of gastrointestinal Graft-versus-Host disease ("GI GVHD"). The FDA has granted the orBec® NDA application...
- Research articles 2006-11-21
- Pipex Pharmaceuticals Plans November NDA Filing for COPREXA Based on Pre-NDA Meetings With FDA
- Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that it completed a series of pre-NDA meetings with the FDA yesterday regarding its lead drug candidate, COPREXA oral tetrathiomolybdate, and that in November Pipex plans...
- Research articles 2007-09-21
- Merck withdraws Arcoxia NDA for now
- Merck has withdrawn a new drug application NDA for Arcoxia etoricoxib, but will resubmit it to the FDA with new efficacy data to support an additional indication for ankylosing spondylitis, described in the Merck Manual as a "heterogeneous and systemic rheumatic disorder characterized by inflammation of the axial skeleton and...
- Research articles 2002-05-01
- FDA Accepts Adeza NDA Filing for Gestiva to Prevent Preterm Births
- SUNNYVALE, Calif. -- Adeza (NASDAQ:ADZA) today announced that the U.S. Food and Drug Administration FDA has accepted for filing the company's New Drug Application NDA for GestivaTM, a long-acting form of a naturally occurring progesterone to prevent preterm birth in women with a history of preterm delivery. In May 2006,...
- Research articles 2006-07-06
- Nuclear Decommissioning Authority (NDA) still on track for April 2005 start; European Commission confirm formal State aids investigation.
- M2 PRESSWIRE-1 December 2004-UK Government: Nuclear Decommissioning Authority NDA still on track for April 2005 start; European Commission confirm formal State aids investigationC1994-2004 M2 COMMUNICATIONS LTD RDATE:12012004 The Government today welcomed the beginning of the European Commission's formal investigation into...
- Research articles 2004-12-01
- Glaxo Submits NDA To FDA For Agenerase.(new drug application; Food and Drug Administration )
- GLAXO WELLCOME has submitted a new drug application NDA to the Food and Drug Administration for Agenerase amprenavir, an HIV protease inhibitor. FDA has granted Agenerase fast-track review status. Glaxo also filed a marketing application with C GLAXO WELLCOME has submitted a new drug...
- Research articles 1998-10-26
- GPC Biotech Begins Rolling NDA Submission for Lead Drug Candidate Satraplatin
- Waltham, Mass. and Princeton, N.J. -- GPC Biotech AG (Frankfurt: GPC) TecDAX index (NASDAQ: GPCB) today announced that the Company has begun the rolling submission of a New Drug Application NDA with the U.S. Food and Drug Administration FDA for satraplatin in combination with prednisone as a second-line chemotherapy treatment...
- Research articles 2005-12-15
- Pfizer delays NDA filing of pregabalin. (Markets: Life Sciences).(Brief Article)
- PFIZER INC. will delay filing its new drug application NDA with the Food and Drug Administration FDA for neuropathic pain drug pregabalin to conduct toxicological studies. Analysts revised earnings per share EPS estimates on a one-year holdup PFIZER INC. will delay filing its new...
- Research articles 2002-09-16
- Alkermes Announces Priority Review Granted for Vivitrex -Naltrexone Long-Acting Injection- NDA Submission
- CAMBRIDGE, Mass. -- Alkermes, Inc. (Nasdaq: ALKS) today announced that the New Drug Application ("NDA") for VivitrexR (naltrexone long-acting injection) has been accepted for review by the United States Food and Drug Administration ("FDA") and has been granted a Priority Review designation. The Prescription Drug User Fee Act ("PDUFA") date...
- Research articles 2005-05-27
- Diatide Announces P829 NDA Receives Priority Classification from FDA; Second of Two NDAs to Receive Priority Classification
- LONDONDERRY, N.H.--BW HealthWire--June 22, 1998--Diatide, Inc. (Nasdaq:DITI) announced today that the United States Food and Drug Administration FDA notified the Company that Diatide's New Drug Application NDA for P829 (kit for the preparation of Technetium Tc 99m Depreotide Injection), for the imaging of malignant tumors in the lung has been...
- Research articles 1998-06-22
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