FDA Offers Draft Guidance on Generic Versions of Opioid Overdose Nasal Spray

While the opiate epidemic continues to spread, the US Food and Drug Administration (FDA) seeks to alleviate some of this pain by providing a new draft guidance to generic drug companies looking to develop generic versions of nasal spray that can Reverse opioid overdose.



The draft guide is intended to help companies understand what studies need to be done to get approval for generic nasal spray Narcan Adaptar Pharma, also known as nasal spray of naloxone hydrochloride.

The narcan nasal spray was originally approved in 2015, and the FDA notes that in November 2016, ADAPT has filed a citizen petition (a tool sometimes used to delay the entry of generic drugs) by asking the FDA to refrain from approving any referral (ANDA) narcan nasal spray, unless certain conditions are met, including conditions related to the demonstration of bioequivalence.

The petition comes as the cost of nasal spray and other forms of naloxone continues to rise.

However, the FDA said that the draft directive is, outside this citizen petition, will respond separately. And the project must begin the process of developing and marketing less expensive versions of naloxone nasal spray.

Project Details

The three-page proposal offers two options: o in vivo in in vitro studies, which reveals the specificities and differences in each of them.

For advice on how to develop a generic drug combination product for approval, the FDA stated its policy titled "Comparative Analysis and Comparative Studies Related to Human Factors for Combined Drug Revenue Device presented an ANDA (January 2017) "Which provides the current thinking of the agency in identifying and evaluating differences in user interface design for a generic drug combination product available from its RLD [drug listed in Reference]."

The FDA also clarifies that at the beginning of product development and / or prior to an ANDA offer, applicants must submit to the Office of Generic Drugs, controlled by correspondence and / or request for a pre-ANDA meeting, "the results of Comparative analysis (eg comparative labeling analysis, comparative analysis of tasks, physical comparison of the constituent part of the distribution device) including an overall assessment of all differences identified between the user interface by T A report to the Product as described in the guidelines referred to above.

EMA Board Adopts New Policy on Whistleblowing

In order to encourage complainants and others to feel secure with possible details of the irregularities, the European Medicines Agency's (EMA) Board of Directors adopted a new policy on Monday detailing how the agency handles allegations , Including those that could have an impact on drug evaluation and monitoring.

Since 2013, EMA says it received a total of 43 of these reports detailing various issues and allegations of drug manufacture in conducting clinical trials.

"While there is no formal policy so far, all reports have been treated in accordance with the principles of the new policy," said EMA, noting that this new policy will help EMA to evaluate all reports and coordinate any further investigation In a structured manner, while protecting the journalist's confidentiality.

politics

Any external entity aware of facts that may have an unequal impact on the authorization, supervision and maintenance of human and veterinary medicines may, in the public interest, be reported to EMA at the following address: @ ema.europa.eu reports .

The BMA says that it will ensure the confidentiality of information from outside sources and the identity of the sources and the protection of personal data, these data lead to a later review by the EMA or the Anti-Fraud Office (OLAF) or do not.

"Examples of claims that can be made to understand that the integrity of the data in the studies used to support the marketing authorization can not be invoked.That integrity is essential to confidence in authorized drugs.These problems can occur due to To the formation of poverty, inadequate application of procedures and controls or even falsification of data, "says the policy.

"If there is a fear that irregularities may affect the balance of drug benefits and risks, EMA's scientific committees may consider regulatory action," the agency said in a statement. If the allegations relate to a drug EMA throughout the authorized country, it may, on a case-by-case basis, refer the matter to the national drug agency of that Member State.

The policy, which came into force on 17 March 2017 and prepared in consultation with the European Commission and OLAF, will be reviewed in three years.