Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines. The FDA Generic Drugs Program conducts a rigorous review to ensure generic medicines meet these standards, in addition to conducting inspections of manufacturing plants and monitoring drug safety after the generic medicine has been approved and brought to market.
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Generic drugs are approved only after a rigorous review by FDA and after a set period of time that the brand product has been on the market exclusively. This is because new drugs, like other new products, are usually protected by patents that prohibit others from making and selling copies of the same drug.
Drug companies must submit an abbreviated new drug application (ANDA) to FDA for approval to market a generic drug that is the same as (or bioequivalent to) the brand product. FDA reviews the application to ensure drug companies have demonstrated that the generic medicine can be substituted for the brand-name medicine that it copies.
What Is the Approval Process for Generic Drugs? Detailed information on the critical factors the FDA reviews to make sure a generic medicine is as safe and effective as the brand-name drug.
Treatment IND is submitted for experimental drugs 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.
CDER's Pre-Investigational New Drug Application (IND) Consultation Program fosters early communications between sponsors and new drug review divisions to provide guidance on the data necessary to warrant IND submission. The review divisions are organized generally along therapeutic class.
CDER's Manual of Policies and Procedures (MaPPs) are approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities. All MAPPs are available for the public to review for a better understanding of office policies, definitions, staff responsibilities and procedures. To find MaPPs of particular interest to IND sponsors, go to CDER Manual of Policies and Procedures and use "INDs" in the search box.
Recently, controlled release (CR) pharmaceutical products have become a very useful tool in medical practice, offering a wide range of actual and perceived advantages to the patient. A CR product requires numerous considerations, like drugs suitable for CR formulations, techniques of fabrication and evaluation, factors affecting bioavailability of the parent drug, before it can actually be claimed to provide the purported benefits. Such complex considerations fall under the domain of pharmaceutical experts and clinicians, naturally, are not sufficiently aware and updated about these products and their biological consequences. Various CR formulations used in neurological practice are discussed in the present review. The clinical studies of the conventional and CR dosage form of the drugs used in neurology practice reflect the advantages of prescribing CR formulations over the conventional dosage forms.
The use of plant or plant-based products to stimulate sexual desire and to enhance performance and enjoyment is almost as old as the human race itself. The present paper reviews the active, natural principles, and crude extracts of plants, which have been useful in sexual disorders, have potential for improving sexual behaviour and performance, and are helpful in spermatogenesis and reproduction. Review of refereed journals and scientific literature available in electronic databases and traditional literature available in India was extensively performed. The work reviews correlation of the evidence with traditional claims, elucidation, and evaluation of a plausible concept governing the usage of plants as aphrodisiac in total. Phytoconstituents with known structures have been classified in appropriate chemical groups and the active crude extracts have been tabulated. Data on their pharmacological activity, mechanism of action, and toxicity are reported. The present review provides an overview of the herbs and their active molecule with claims for improvement of sexual behaviour. A number of herbal drugs have been validated for their effect on sexual behavior and fertility and can therefore serve as basis for the identification of new chemical leads useful in sexual and erectile dysfunction.
Advancement in the understanding of pharmacological basis of erectile and sexual functions at molecular levels is turning out to be stepping stones towards isolating the crucial physiologic factors involved in sexual arousal, thus helping to narrow down the search for aphrodisiac substances of choice. Many people do not believe in love potions or aphrodisiacs, but countless numbers of men and women have used them down through the centuries, and there is clear proof that they are still in use today. The skepticism towards the concept of aphrodisiac is not unjustified, although a systematic evaluation and compilation of scientific information may provide a basis for the evidence-based utilization of herbal drugs for treatment of sexual dysfunction in general. The present review is an attempt to consummate the available scientific information on various herbal drugs, which have been evaluated for their effect on sexual performance and functionality. The review also includes known evidences collected for the involvement of herbal drugs on neural, nitric oxide and hormone-dependent mechanisms and their role on sexual functions. A number of plants have been discussed in detail and a few others are only tabulated; a major criterion for this arrangement was the ethnopharmacological relevance of the plant in the Ayurvedic system of medicine. Nonetheless, it is very important to mention that this does not entail a grading system for the plants described in the paper and some of the plants only listed in tabular form may also be of high scientific relevance.
The Cochrane Database of Systematic Reviews is a collection of evidence-based reviews produced by the Cochrane Library, an international nonprofit organization. The reviews summarize the results of clinical trials on health care interventions. Summaries are free; full-text reviews are by subscription only. 2ff7e9595c
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