drug annual report

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2020 NSDUH Annual National Report

Read key findings from the 2020 National Survey on Drug Use and Health (NSDUH) on substance use, mental health, and treatment by age group. Metrics in the report cover the civilian, noninstitutionalized US population ages 12 and older. Unlike other NSDUH Annual National Reports, the 2020 report has no comparisons to the previous year, because changes in survey methodology mean the indicators are not comparable to past NSDUH estimates.

Along with the full report, a set of slides is available that displays figures from the report. An errata document with corrected information was added in January 2023.

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2012 Annual Returned Drug Report

2011 annual returned drug report, 2010 annual returned drug report.

Annual Returned Drug Reports

2023 annual return of drugs report.

2022 Annual Return of Drugs Report

2021 Annual Return of Drugs Report

2020 Annual Return of Drugs Report

2019 Annual Return of Drugs Report

2018 Annual Return of Drugs Report

2017 Annual Return of Drugs Report

2016 Annual Return of Drugs Report

2015 Annual Return of Drugs Report

2014 Annual Return of Drugs Report

2013 Annual Return of Drugs Report

26. NDA and ANDA Annual reports

New Drug Application (NDA): The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.

An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.

NDA and ANDA Annual reports:

NDA and ANDA Annual reports should be submitted each year within 60 days of the anniversary date of U.S. approval of the application.

These reports required to be accompanied by a completed transmittal Form FDA 2252 (Transmittal of Periodic Reports for Drugs for Human Use), and must include all the information required under this section that the manufacturer received or otherwise obtained during the annual reporting interval that ends on the U.S. anniversary date.

The report includes:

1. Summary: A brief summary of significant new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product, brief description of actions that manufacturer has taken or intends to take as a result of this new information, labeling supplements for pediatric use and whether new studies in the pediatric population to support appropriate labeling for the pediatric population have been initiated. Where possible, an estimate of patient exposure to the drug product, with special reference to the pediatric population (neonates, infants, children, and adolescents) shall be provided, including dosage form.

2. Distribution data: Information about the quantity of the drug product distributed under the approved application, including that distributed to distributors. The information is required to include the National Drug Code (NDC) number, the total number of dosage units of each strength or potency distributed (e.g., 100,000/5 milligram tablets, 50,000/10 milliliter vials), and the quantities distributed for domestic use and the quantities distributed for foreign use.

Authorized generic drugs. If applicable, the date each authorized generic drug entered the market, the date each authorized generic drug ceased being distributed, and the corresponding trade or brand name. Each dosage form and/or strength is a different authorized generic drug and should be listed separately.

3. Labeling.

4. Chemistry, manufacturing, and controls changes:

( a ) Reports of experiences, investigations, studies, or tests involving chemical or physical properties, or any other properties of the drug (such as the drug’s behavior or properties in relation to microorganisms, including both the effects of the drug on microorganisms and the effects of microorganisms on the drug). These reports are only required for new information that may affect FDA’s previous conclusions about the safety or effectiveness of the drug product.

( b ) A full description of the manufacturing and controls changes not requiring a supplemental application.

5. Nonclinical laboratory studies. Copies of unpublished reports and summaries of published reports of new toxicological findings in animal studies and in vitro studies (e.g., mutagenicity) concerning the ingredients in the drug product.

6. Clinical data.

( a ) Published clinical trials of the drug (or abstracts of them), including clinical trials on safety and effectiveness; clinical trials on new uses; biopharmaceutic, pharmacokinetic, and clinical pharmacology studies; and reports of clinical experience pertinent to safety (for example, epidemiologic studies or analyses of experience in a monitored series of patients). Review articles, papers describing the use of the drug product in medical practice, papers and abstracts in which the drug is used as a research tool, promotional articles, press clippings, and papers that do not contain tabulations or summaries of original data should not be reported.

( b ) Summaries of completed unpublished clinical trials, or prepublication manuscripts if available.

( c ) Analysis of available safety and efficacy data in the paediatric population and changes proposed in the labeling based on this information. An assessment of data needed to ensure appropriate labeling for the pediatric population shall be included.

7. Status reports of postmarketing study commitments. A status report of each postmarketing study of the drug product concerning clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology that is required by FDA or that the applicant has committed, in writing, to conduct either at the time of approval of an application for the drug product or a supplement to an application, or after approval of the application or a supplement. For pediatric studies, the status report shall include a statement indicating whether postmarketing clinical studies in pediatric populations were required by FDA.

( a ) Content of status report. The following information must be provided for each postmarketing study reported under this paragraph:

( 1 ) Applicant’s name.

( 2 ) Product name. Include the approved drug product’s established name and proprietary name, if any.

( 3 ) NDA, ANDA, and supplement number.

( 4 ) Date of U.S. approval of NDA or ANDA.

( 5 ) Date of postmarketing study commitment.

( 6 ) Description of postmarketing study commitment. The description must include sufficient information to uniquely describe the study. This information may include the purpose of the study, the type of study, the patient population addressed by the study and the indication(s) and dosage(s) that are to be studied.

( 7 ) Schedule for completion and reporting of the postmarketing study commitment. The schedule should include the actual or projected dates for submission of the study protocol to FDA, completion of patient accrual or initiation of an animal study, completion of the study, submission of the final study report to FDA, and any additional milestones or submissions for which projected dates were specified as part of the commitment. In addition, it should include a revised schedule, as appropriate. If the schedule has been previously revised, provide both the original schedule and the most recent, previously submitted revision.

( 8 ) Current status of the postmarketing study commitment. The status of each postmarketing study should be categorized using one of the following terms that describes the study’s status on the anniversary date of U.S. approval of the application or other agreed upon date:

( i ) Pending. The study has not been initiated, but does not meet the criterion for delayed.

( ii ) Ongoing. The study is proceeding according to or ahead of the original schedule.

( iii ) Delayed. The study is behind the original schedule.

( iv ) Terminated. The study was ended before completion but a final study report has not been submitted to FDA.

( v ) Submitted. The study has been completed or terminated and a final study report has been submitted to FDA.

( 9 ) Explanation of the study’s status. Provide a brief description of the status of the study, including the patient accrual rate (expressed by providing the number of patients or subjects enrolled to date, and the total planned enrollment), and an explanation of the study’s status. If the study has been completed, include the date the study was completed and the date the final study report was submitted to FDA, as applicable.

( b ) Public disclosure of information. Except for the information described in this paragraph, FDA may publicly disclose any information concerning a postmarketing study, if the agency determines that the information is necessary to identify the manufacturer or to establish the status of the study, including the reasons, if any, for failure to conduct, complete, and report the study.

8. Status of other postmarketing studies. A status report is to be included for any chemistry, manufacturing, and controls studies that the applicant has agreed to perform and for all product stability studies.

9. Log of outstanding regulatory business. To facilitate communications between FDA and the manufacturer, the report may, at the manufacturer’s discretion, also contain a list of any open regulatory business with FDA concerning the drug product subject to the application.

RPD: Decrease in violent crimes, increase in drug overdoses in 2022 annual report

Compared with 2021, sexual assaults dropped 19.8%, simple assaults dropped 16.4%, and kidnapping dropped 47%..

ROCHESTER — The Rochester Police Department released its annual report for 2022, showing the summation of its activities.

RPD Chief Jim Franklin wrote that the report shows "a decrease in violent crime but an increase in drug overdoses and calls for service involving people in crisis."

According to the report, 2022 included one murder/non-negligent manslaughter, one negligent manslaughter, one justifiable homicide, 10 kidnappings, 137 sexual assaults, 32 robberies, 194 aggravated assaults, 524 simple assaults, five arson cases, and 256 burglaries.

When compared with 2021, sexual assaults dropped 19.8%, simple assaults dropped 16.4%, and kidnapping dropped 47%.

Aggravated assaults dropped 20.8% compared with 2021, but 2021 had a 29% increase over 2020.

The department seized 55 guns, six vehicles, and nearly $61,000.

The illegal substances seized by the police department included nearly 59 pounds of methamphetamine, 31 pounds of marijuana, 10 grams of heroin, 13.6 grams of crack, 80 pounds of fentanyl, 82 pounds of cocaine, and 17 pounds of Ketamine.

In addition to its reactive work, the police department also outlined a number of the proactive roles it engaged in throughout the city. Examples include having a booth at Thursdays Downtown, taking part in Skate City Nights, hosting Coffee with a Cop at 125 Live, and helping with Shop with a Cop during the holiday season.

The police department has also partnered with Rochester Public Schools on a student driver mentorship program, which is aimed at "students who historically have not had access."

The Rochester Police Department also expanded its collaboration with the Mayo Clinic "to include five hospital resource officers." The officers responded to 2,314 calls in 2022.

See the full report:

RPD 2022 annual report shows drop in major crime; spike in drug overdoses, person in crisis calls

Courtesy: Rochester Police Department

(ABC 6 News) – The Rochester Police Department (RPD) released its 2022 annual report on Thursday.

In 2022, RPD officers responded to 57,591 calls for service. Drug overdoes jumped 29% from 2021. Officers responded to 120 drug overdoses, including 22 deaths. RPD officers administered Narcan, a life-saving medication that can quickly reverse an overdose by blocking the effects of opioids, 49 times.

Person in crisis calls – involving individuals experiencing a mental health emergency – continued to rise as officers responded to 1,692 calls , an 8% increase from 2021.

Major crimes such as murder, sexual assault, kidnapping, robbery, and burglary were at four-year lows. See the full chart below.

The Investigations Team which follows up with and provides detailed investigations on crimes committed in the City of Rochester, was assigned 2,453 cases – a 19% increase from 2021. Death investigation ( 142% ), forgery ( 112% ) and shoplifting ( 378% ) all saw increases while damage to property ( 40% ) saw a decrease from 2021. The team also executed approximately 61 residential-type search warrants, 8 more than in 2021 and none were a no-knock warrant.

RPD also seized 55 handguns, 79.9 pounds of fentanyl, 82.4 pounds of cocaine, 31.2 pounds of marijuana, 58.86 pounds of methamphetamine, 10 grams of heroin, and 39,400 fentanyl pills (approximate quantity based on weight).

The report also said catalytic converter theft continued to climb in Rochester as RPD received reports of 157 catalytic converters stolen or damaged.

RPD hired 15 new officers in 2022, nearly half were women and people of color. They completed the departments 10-week, in-house training academy before being sworn-in.

To view the full report, CLICK HERE .

IMAGES

Fight the New Drug Annual Report 2015 by Fight the New Drug
FDA Reports
Orphan Drug Report
Detailed Drug Report 2009OSDUHS Final Web
IND Annual Report Template:
Fight the New Drug Annual Report 2017 by Fight the New Drug

VIDEO

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DHEC’s annual drug overdose report shows rise in fatal overdoses
DHEC’s annual drug overdose report shows rise in fatal overdoses (11:00 p.m. Show)
Drug Regulattory Affairs CMC Simplified Overview
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Myanmar: Opium cultivation surges, UN report says surge under military rule

COMMENTS

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World Drug Report 2022
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This page provides the publications produced by the NFLIS-DRUG, NFLIS-TOX, and NFLIS-MEC programs. These include quarterly, midyear, annual, special reports and other reports, as well as briefs, maps, data tables and data lists.
Drug Utilization Review Annual Report
On an annual basis, states are required to report on their practitioners prescribing habits, cost savings generated from their Drug Utilization Review (DUR) programs and their program's operations, including adoption of new innovative DUR practices via the Medicaid Drug Utilization Review Annual Report Survey.
eCFR :: 21 CFR 316.30 -- Annual reports of holder of orphan-drug
§ 316.30 Annual reports of holder of orphan-drug designation. Within 14 months after the date on which a drug was designated as an orphan drug and annually thereafter until marketing approval, the sponsor of a designated drug shall submit a brief progress report to the FDA Office of Orphan Products Development on the drug that includes:
Drug Policy Alliance Annual Report
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CFR
Sec. 316.30 Annual reports of holder of orphan-drug designation. Within 14 months after the date on which a drug was designated as an orphan drug and annually thereafter until marketing...
2021 NSDUH Annual National Report
2021 NSDUH Annual National Report Description: Read key findings from the 2021 National Survey on Drug Use and Health (NSDUH) on substance use, mental health, and treatment. Metrics in the report cover the civilian, noninstitutionalized US population ages 12 and older.
2020 NSDUH Annual National Report
2020 NSDUH Annual National Report Description: Read key findings from the 2020 National Survey on Drug Use and Health (NSDUH) on substance use, mental health, and treatment by age group. Metrics in the report cover the civilian, noninstitutionalized US population ages 12 and older.
PDF Department of Health Care Services Pharmacy Benefits Division MEMORANDUM
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Annual Drug Reports
Annual Returned Drug Reports. 2023 Annual Return of Drugs Report. 2022 Annual Return of Drugs Report. 2021 Annual Return of Drugs Report. 2020 Annual Return of Drugs Report. 2019 Annual Return of Drugs Report. 2018 Annual Return of Drugs Report. 2017 Annual Return of Drugs Report. 2016 Annual Return of Drugs Report ...
26. NDA and ANDA Annual reports
These reports required to be accompanied by a completed transmittal Form FDA 2252 (Transmittal of Periodic Reports for Drugs for Human Use), and must include all the information required under this section that the manufacturer received or otherwise obtained during the annual reporting interval that ends on the U.S. anniversary date.
RPD: Decrease in violent crimes, increase in drug overdoses in 2022
RPD: Decrease in violent crimes, increase in drug overdoses in 2022 annual report Compared with 2021, sexual assaults dropped 19.8%, simple assaults dropped 16.4%, and kidnapping dropped 47%.
RPD 2022 annual report shows drop in major crime; spike in drug
(ABC 6 News) - The Rochester Police Department (RPD) released its 2022 annual report on Thursday. In 2022, RPD officers responded to 57,591 calls for service. Drug overdoes jumped 29% from 2021 ...