Abbreviated New Drug Application Process: A Gift for The Industry and The Patients

2021 ◽  
pp. 331-335
Author(s):  
Hindustan Abdul Ahad ◽  
Haranath Chinthaginjala ◽  
Gangireddy Jayasimha Reddy ◽  
Pasupuleti Dheeraj Krishna ◽  
Syed Rahamathulla ◽  
...  
Keyword(s):  
Drug Application ◽  
The United States ◽  
New Drugs ◽  
Brand Name ◽  
Application Process ◽  
Drug Products ◽  
Federal Food ◽  
United States Food ◽  
States Food ◽  
New Drug Application

The United States Food and Drug Administration (USFDA) is one of the main regulated agencies wherein the submission and approval of the new drugs is done. This review is based on the process of submission to the ANDA as per FDA norms as described in paragraph IV submission in Federal Food, Drug, and Cosmetic Act (FD and C Act). No drug would exist in the market until it gets accepted by regulatory authorities. The ANDA submission is for those firms seeking to copy branded drugs before running out of patents to get profit on them. A generic applicant must provide in its application a "certification" that a patent submitted to FDA by the brand-name drug's sponsor and scheduled in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). A Generic Product must meet the standards recognized by FDA in Reference listed drugs (RLD). This study concludes the process of ANDA submission to FDA and acts correlated to the submission in paragraph IV, the details of ANDA filling in the eCTD format and overview of the review process the checklist to the applicant.

scholarly journals Analysis of Crowdsourced Metformin Tablets from Individuals Reveals Widespread Contamination with N-Nitrosodimethylamine (NDMA) in the United States

2020 ◽  
Author(s):  
Qian Wu ◽  
Evgenia Kvitko ◽  
Amber Jessop ◽  
Shannon Williams ◽  
Ryan C. Costantino ◽  
...  
Keyword(s):  
United States ◽  
High Resolution Mass Spectrometry ◽  
Daily Intake ◽  
The United States ◽  
Product Recalls ◽  
Acceptable Daily Intake ◽  
Drug Products ◽  
Post Market ◽  
United States Food ◽  
States Food

AbstractRecent reports of metformin drug products contaminated with unacceptable levels of the probable human carcinogen N-Nitrosodimethylamine (NDMA) prompted a national sampling of post-market metformin drug products. To most broadly sample the market and minimize supply chain bias, metformin medication samples were crowdsourced directly from individuals across many states in the United States. 128 samples were received, and liquid chromatography-high resolution mass spectrometry tests for a panel of nitrosamines revealed significant levels of NDMA that trend with labeling company. 42% of all medication samples contained detectable levels of NDMA and, when scaled to maximum daily tablet dose, 36% of all medication samples contained NDMA levels exceeding the FDA daily acceptable intake limit. The highest NDMA detection from the tested samples was 1565 ng per tablet, which, when commonly taken four times a day, is 65 times the United States Food and Drug Administration (FDA) acceptable daily intake limit. Results underscore the need for immediate product recalls of tainted medications and an overall investigation of metformin manufacturing practices.

An Examination of the Drug Review Process Within the United States

1994 ◽  
Vol 13 (2) ◽  
pp. 121-142 ◽  
Author(s):  
Phillip A. Johns
Keyword(s):  
Drug Development ◽  
Development Time ◽  
Review Process ◽  
Drug Application ◽  
The United States ◽  
New Drugs ◽  
Total Drug ◽  
Scientific Approach ◽  
New Drug Application ◽  
Drug Review

A general overview of the drug review process is presented with emphasis on non-clinical approaches for gaining acceptable exemptions for investigational use of new drugs. Selected non-clinical requirements for approval of marketing or the new drug application are also discussed. Particular attention is given to the trend towards a more rational, scientific approach to the design of studies that are intended to elucidate issues of safety and efficacy. The fundamental purpose of these new approaches is to reduce drug development time and expense and bring newer and better drug therapies to patients. Newer requirements for the conduct and use of kinetics earlier in development are emphasized. The relevance of meetings with the Food and Drug Administration and the effects that meetings are reported to have had on total drug development time are also discussed.

scholarly journals A Broadly Accessible Liquid Chromatography Method for Quantification of Six Nitrosamine Compounds and N,N-Dimethylformamide in Metformin Drug Products Using High Resolution Mass Spectrometry

2020 ◽  
Author(s):  
Qian Wu ◽  
Evgenia Kvitko ◽  
Nicola Zenzola ◽  
Kaury Kucera ◽  
David Light
Keyword(s):  
High Resolution Mass Spectrometry ◽  
The United States ◽  
High Mass ◽  
Chromatography Method ◽  
Drug Products ◽  
Regulatory Guidance ◽  
High Mass Resolution ◽  
United States Food ◽  
States Food ◽  
Liquid Chromatography Method

N-nitrosodimethylamine (NDMA) and the industrial solvent, N,N-dimethylformamide (DMF), are both probable human carcinogens that have been detected in pharmaceutical drug products like metformin, which is used to treat type II diabetes. Some lots of metformin drug products have exceeded the United States Food and Drug Administration (FDA) daily allowable intake limit for NDMA, while the presence of DMF has been detected at several orders of magnitude higher than NDMA. A recent study found that a low abundance isotope of DMF interferes with NDMA quantification by using a unique subset of LC-MS instruments capable of high mass resolution. In this study, an LC-HRMS method is developed that chromatographically separates NDMA from DMF in metformin drug products to eliminate interference. The method can detect nitrosamines and DMF under the current regulatory guidance for industry and provides a solution for simultaneously quantifying nitrosamines and DMF for a broad range of LC-MS instruments.

Present Status of Supplemental Application Submission in USFDA

2018 ◽  
Vol 9 (3) ◽  
Author(s):  
Verma S ◽  
Misri P ◽  
Yashwant . ◽  
Haque A
Keyword(s):  
United States ◽  
Drug Administration ◽  
Present Status ◽  
Drug Product ◽  
Food And Drug Administration ◽  
Drug Application ◽  
The United States ◽  
United States Food ◽  
States Food ◽  
Year 2000

Objective: In order to reach to the market, a drug product has to undergo various phases of scrutiny assuring its quality, safety and efficacy. Once the experimental drug promises its safety, efficacy and quality it is permitted to be marketed by the regulator. The drug is still present under surveillance for possibility of any adverse drug reaction or any other alteration or a new indication. If any modification is to be done, then the applicant/sponsor needs to file a supplemental application. This article provides information about present status of supplemental new drug application submitted and approved to the United States food and drug administration. Materials and methods: The data have been archived from the official website of United States food and drug administration comprising all the applications approved by this regulatory agency from the year 2000 to 2016. The data has been segregated and statistically analyzed using ANOVA on the basis of different categories of approved applications. Results: As per the analysis, from the year 2000 to 2016, a total of 69,585 applications was filed to USFDA, amongst which 9499 were original applications and 60,086 were supplemental applications.

Regulating language, not inference: an examination of the potential effectiveness of Natural American Spirit advertising restrictions

2019 ◽  
Vol 28 (e1) ◽  
pp. e43-e48 ◽  
Author(s):  
Stefanie K Gratale ◽  
Erin K Maloney ◽  
Joseph N Cappella
Keyword(s):  
The United States ◽  
Santa Fe ◽  
Brand Name ◽  
Potential Effectiveness ◽  
Original Language ◽  
Mediated Effects ◽  
United States Food ◽  
States Food ◽  
Former Smokers ◽  
Advertising Restrictions

ObjectiveIn 2017, the United States Food and Drug Administration (FDA) reached an agreement with Santa Fe Natural Tobacco Company (SFNTC) stipulating that SFNTC will remove ‘natural’ and ‘additive-free’ from Natural American Spirit (NAS) marketing to combat misperceptions that NAS is a healthier cigarette. The purpose of this study was to assess experimentally the potential effectiveness of the agreement in addressing NAS misperceptions.MethodsIn an online experiment, 820 current and former smokers were assigned randomly to advertising conditions with existing claims from NAS advertisements, modified claims or a no-exposure control. Advertising conditions included (1) ‘original’ NAS advertising text before the agreement; (2) ‘2017 agreement’ language permissible under the FDA–SFNTC agreement (removing ‘natural’, ‘additive-free’); (3) more restrictive (‘stricter’) language representing additional regulation (removing ‘natural’ from the brand name and the phrases ‘tobacco+water’, ‘no chemicals’). Participants completed outcome measures assessing misinformed beliefs and intentions towards NAS.ResultsOne-way ANOVA showed that relative to the ‘original’ language, the ‘2017 agreement’ language reduced misconceptions about NAS addictiveness, but not about health or constituent composition. Yet ‘stricter’ language significantly reduced all categories of misinformed beliefs, which in turn mediated effects on (lower) intentions to use NAS.ConclusionThe 2017 agreement helps dispel some misconceptions about NAS addictiveness, but does not sufficiently rectify misinformation about health or composition. Since ‘stricter’ language more effectively corrects misinformed beliefs, our results suggest the need for further regulations in addressing misinformation that drives intentions towards NAS.

scholarly journals Anesthetic and Analgesic Drug Products Advisory Committee Activity and Decisions in the Opioid-crisis Era

2020 ◽  
Vol 133 (4) ◽  
pp. 740-749 ◽  
Author(s):  
Ronald S. Litman
Keyword(s):  
United States ◽  
Advisory Committee ◽  
Drug Administration ◽  
Drug Product ◽  
Food And Drug Administration ◽  
The United States ◽  
New Drugs ◽  
Analgesic Drug ◽  
Drug Products ◽  
United States Food

The United States Food and Drug Administration is tasked with ensuring the efficacy and safety of medications marketed in the United States. One of their primary responsibilities is to approve the entry of new drugs into the marketplace, based on the drug’s perceived benefit–risk relationship. The Anesthetic and Analgesic Drug Product Advisory Committee is composed of experts in anesthesiology, pain management, and biostatistics, as well as consumer and industry representatives, who meet several times annually to review new anesthetic-related drugs, those seeking new indications, and nearly every opioid-related application for approval. The following report describes noteworthy activities of this committee since 2017, as it has grappled, along with the Food and Drug Administration, to balance the benefit–risk relationships for individual patients along with the overarching public health implications of bringing additional opioids to market. All anesthesia advisory committee meetings since 2017 will be described, and six will be highlighted, each with representative considerations for potential new opioid formulations or local anesthetics.

scholarly journals 2018 FDA Tides Harvest

2019 ◽  
Vol 12 (2) ◽  
pp. 52 ◽  
Author(s):  
Danah Al Shaer ◽  
Othman Al Musaimi ◽  
Fernando Albericio ◽  
Beatriz de la Torre
Keyword(s):  
United States ◽  
Drug Administration ◽  
Mode Of Action ◽  
Chemical Structure ◽  
Food And Drug Administration ◽  
The United States ◽  
New Drugs ◽  
Target Mode ◽  
United States Food ◽  
States Food

In 2018, the United States Food and Drug Administration (FDA) approved a total of 59 new drugs, three of them (5%) are TIDES (or also, -tides), two oligonucleotides and one peptide. Herein, the three TIDES approved are analyzed in terms of medical target, mode of action, chemical structure, and economics.

The Scope and Challenges of Vesicular Carrier-Mediated Delivery of Docetaxel for the Management of Cancer

2020 ◽  
Vol 17 (10) ◽  
pp. 874-884
Author(s):  
Charu Misra ◽  
Kaisar Raza ◽  
Amit Kumar Goyal
Keyword(s):  
The United States ◽  
Drug Products ◽  
Cancer Management ◽  
Vesicular Carriers ◽  
The Us ◽  
United States Food ◽  
Potential Benefits ◽  
States Food ◽  
Us Fda ◽  
Novel Drug

Since the discovery of liposomes, these vesicular carriers have attracted the researchers from all the vistas of the biomedical domain to explore and harness the potential benefits. Many novel drug delivery-based products have been approved by the United States Food and Drug Administration (USFDA) and other federal agencies of the globe, out of which the major share is of the liposomes and related carriers. Taking cognizance of it, the US-FDA has recently come up with ‘Guidance for Industry on Liposome Drug Products’. In cancer management, chemotherapy is the most frequently employed approach which is still not devoid of untoward challenges and side effects. In chemotherapy, the taxanes, esp. Docetaxel shares a huge percentage in the prescription pattern. Also, the first marketed liposomal product was encasing one drug of this category. Henceforth, the present review will highlight the advances in the delivery of taxanes, in particular docetaxel, with an emphasis on the need, success and pharmacoeconomic aspects of such vesicular-carrier mediated docetaxel delivery.

scholarly journals Performance evaluation of a prescription medication image classification model: an observational cohort

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Corey A. Lester ◽  
Jiazhao Li ◽  
Yuting Ding ◽  
Brigid Rowell ◽  
Jessie ‘Xi’ Yang ◽  
...  
Keyword(s):  
Prescription Medication ◽  
The United States ◽  
Machine Intelligence ◽  
Classification Model ◽  
Drug Products ◽  
National Drug ◽  
Physical Form ◽  
United States Food ◽  
Observational Cohort ◽  
States Food

AbstractTechnology assistance of pharmacist verification tasks through the use of machine intelligence has the potential to detect dangerous and costly pharmacy dispensing errors. National Drug Codes (NDC) are unique numeric identifiers of prescription drug products for the United States Food and Drug Administration. The physical form of the medication, often tablets and capsules, captures the unique features of the NDC product to help ensure patients receive the same medication product inside their prescription bottle as is found on the label from a pharmacy. We report and evaluate using an automated check to predict the shape, color, and NDC for images showing a pile of pills inside a prescription bottle. In a test set containing 65,274 images of 345 NDC classes, overall macro-average precision was 98.5%. Patterns of incorrect NDC predictions based on similar colors, shapes, and imprints of pills were identified and recommendations to improve the model are provided.

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