Every pharmaceutical company in world is looking at having its pharmaceutical business spread in western countries like USA or EUROPE.
We are happy to provide articles about pharmaceutical regulatory affairs with respect to US FDA , we are focused to provide detailed information on following topics
1.What is an ( pharmaceutical ) Investigational New Drug Application (IND) Provides resources to assist drug sponsors with submitting applications for approval to begin new drug experiments on human subjects.
2.How to do drug Applications submission to us fda for Over-the-Counter Drugs
3.What is ( pharmaceutical ) Abbreviated New Drug Application (ANDA) Provides resources to assist drug sponsors with submitting applications to market a generic drug.
Read where ever it is written as “we” as US FDA and “agency” as or means US FDA and its Regulatory agencies.
Investigational New Drug (IND) Application
Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.
During a new drug’s pharmaceutical early preclinical development, the sponsor’s primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
FDA’s role in the development of a new ( pharmaceutical ) drug begins when the drug’s sponsor (usually the manufacturer or potential marketer) having screened the new molecule for pharmacological activity and acute toxicity potential in animals, wants to test its diagnostic or therapeutic potential in humans. At that point, the molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specific requirements of the drug regulatory system.or pharmaceutical regulatory systems
There are three IND types:
1.An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
2.Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR , Sec. 312.23 or Sec. 312.34. It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.
3.Treatment IND is submitted for experimental drugs (pharmaceuticals ) showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.
There are two IND categories:
The IND application must contain information in three broad areas:
1.Animal Pharmacology and Toxicology Studies – Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug ( pharmaceutical ) in humans (often foreign use).
2.Manufacturing Information – Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
3.Clinical Protocols and Investigator Information – Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators–professionals (generally physicians) who oversee the administration of the experimental compound–to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
Resources for IND Applications
The following resources have been gathered to provide you with the legal requirements of an IND application, assistance from CDER to help you meet those requirements, and internal IND review principles, policies and procedures.
Pre-IND Consultation Program: CDER offers a Pre-Investigational New Drug Application (IND) Consultation Program to foster early communications between sponsors and new drug review divisions in order to provide guidance on the data necessary to warrant IND submission. The review divisions are organized generally along therapeutic class and can each be contacted using the designated Pre-IND Consultation List.
Guidance Documents for INDs , Are available over US FDA’S website for pharmaceuticals regulatory
Guidance documents represent the Agency’s current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products. They also establish policies intended to achieve consistency in the Agency’s regulatory approach and establish inspection and enforcement procedures. Because guidances are not regulations or laws, they are not enforceable, either through administrative actions or through the courts. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office.
For the complete list of CDER guidances, please see US FDA’S website for these guidance documents.
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