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302. Shaping Medicaid and SCHIP through waivers: the fundamentals

nlm:nlmuid-101490563-pdf

307. The Medicare drug benefit coverage gap: the basics

nlm:nlmuid-101554803-pdf

308. National spending for long-term services and supports (LTSS): the basics

nlm:nlmuid-101561786-pdf

310. Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff

nlm:nlmuid-101719787-pdf

315. Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719815-pdf

316. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719834-pdf

317. Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719840-pdf

320. Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff

nlm:nlmuid-101719884-pdf

323. Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff

nlm:nlmuid-101719888-pdf

324. Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719889-pdf

327. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment

nlm:nlmuid-101719919-pdf

328. Recurrent herpes labialis: developing drugs for treatment and prevention

nlm:nlmuid-101719926-pdf

330. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719954-pdf

331. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception

nlm:nlmuid-101719973-pdf

333. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

nlm:nlmuid-101719981-pdf

334. Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719987-pdf

335. Nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV): testing, product disposition, and donor deferral and reentry

nlm:nlmuid-101719989-pdf

336. FDA categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions: guidance for sponsors, clinical investigators, industry, institutional review boards, and Food and Drug Administration staff

nlm:nlmuid-101719990-pdf

337. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101720001-pdf

338. Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components

nlm:nlmuid-101720003-pdf

342. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

nlm:nlmuid-101720038-pdf

344. Unique device identification: policy regarding compliance dates for class I and unclassified devices : immediately in effect guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101720053-pdf

348. Fourth partial report on Project no. 37 -- study of errors in field artillery practice: subject: an analysis of the sources of error in the use of the aiming circle and development of an improved instrument

nlm:nlmuid-101678214-bk

362. Second partial report on Project no. 37 -- study of errors in field artillery practice: subject: an analysis of the sources of error in the use of the panoramic telescope M12 and development of principles of design for an improved instrument

nlm:nlmuid-101678178-bk

368. Data inadequacies undermine CMS's oversight of the inconsistency resolution process for the federal marketplace

nlm:nlmuid-101737746-pdf

369. CMS validated hospital inpatient quality reporting program data, but should use additional tools to identify gaming

nlm:nlmuid-101737750-pdf

371. CDC generally met its inspection goals for the federal select agent program: however, opportunities exist to strengthen oversight

nlm:nlmuid-101737763-pdf

373. Round 2 competitive bidding for CPAP/RAD: disrupted access unlikely for devices, inconclusive for supplies

nlm:nlmuid-101737773-pdf

375. OHRP generally conducted its compliance activities independently, but changes would strengthen its independence

nlm:nlmuid-101737781-pdf

376. HHS's Office of Refugee Resettlement improved coordination and outreach to promote the safety and well-being of unaccompanied alien children

nlm:nlmuid-101737785-pdf

377. Medicare program shared savings accountable care organizations have shown potential for reducing spending and improving quality

nlm:nlmuid-101737819-pdf

389. Enhancements needed in the tracking and collection of Medicare overpayments identified by ZPICS and PSCS

nlm:nlmuid-101737930-pdf

393. Medicare payments for clinical diagnostic laboratory tests in 2016: year 3 of baseline data

nlm:nlmuid-101737978-pdf

394. Excluding noncovered versions when setting payment for two Part B drugs would have resulted in lower drug costs for Medicare and its beneficiaries

nlm:nlmuid-101737981-pdf

396. Followup review: CMS's management of the quality payment program

nlm:nlmuid-101737984-pdf

397. Potential misclassifications reported by drug manufacturers may have led to $1 billion in lost Medicaid rebates

nlm:nlmuid-101737986-pdf