FDA Law Blog

NOVEMBER 27, 2023

the “Gree Companies”), an appliance manufacturer and two of its subsidiaries that were involved in the manufacturing, marketing, and sale of dehumidifiers. At the time, in 2016, the Gree Companies’ settlement for $15.45 It is a long story that started more than a decade ago. It involved Gree Electric Appliances Inc.

Government 104

Government Insurance Manufacturing Individual 104

FDA Law Blog

DECEMBER 1, 2024

The current Warning Letter was issued to a drug manufacturer in China (Tianjin Darentang Jingwanhong Pharmaceutical Co., In September 2016, Nippon Fine Chemical received a similar Warning Letter about an attempt to prevent an FDA Investigator from taking photographs.

Management 113

Management IT Manufacturing Provider 113

FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. products intended for medical purposes).

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

APRIL 2, 2025

In that pre- Loper Bright case, FDA successfully defended its 2016 GRAS final rule. FDA and the court agreed that the law does not require manufacturers to get preapproval before using a substance the manufacturer believes to be GRAS. Congress does not, one might say, hide elephants in mouseholes.

Manufacturing 59

Manufacturing Government IT 59

FDA Law Blog

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” By Philip Won & Jeffrey K. This provision became effective as of March 29, 2023.

Specialization 105

Specialization Provider Medical Manufacturing 105

FDA Law Blog

FEBRUARY 21, 2024

It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. It also specifies that manufacturers document the Unique Device Identifier (UDI) for each medical device or batch of medical devices in accordance with Part 830, Unique Device Identification.

Manufacturing 59

Manufacturing Management Medical IT 59

FDA Law Blog

APRIL 22, 2024

When DEA denied marijuana rescheduling petitions in August 2016, cannabis was listed as a schedule I and schedule IV substance under the Single Convention. marijuana manufacturers, importers, exporters, and distributors will be required to obtain DEA registrations, and prescriptions will be required for dispensing marijuana to individuals.

Manufacturing 59

Manufacturing Consulting IT Individual 59

FDA Law Blog

MAY 31, 2021

One of these amendments was a poorly thought-out rule that, if implemented, will render virtually unusable the current best price exclusion for manufacturer patient savings programs in the form of coupons, patient rebates/refunds, copay assistance, vouchers, and free drug programs. The effective date of this amendment is January 1, 2023.

Manufacturing 52

Manufacturing Insurance Patients IT 52

FDA Law Blog

AUGUST 8, 2024

Rescheduling or descheduling from the most stringent schedule under the CSA, should one of those actions occur, would loosen federal manufacturing, import/export, distribution, and security requirements. 12, 2016); Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed. 53,688 (Aug. 53,767 (Aug. 21 U.S.C. §

Government 59

Government Medical IT Manufacturing 59

FDA Law Blog

MARCH 6, 2022

This international standard is the 2016 edition of ISO 13485, issued by the International Organization for Standardization (ISO). It is very common for a medical device manufacturing facility both to be certified as compliant with ISO 13485 and to have quality system procedures designed to comply with the FDA’s QSR.

Manufacturing 52

Manufacturing Management Medical Provider 52

FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

Manufacturing 64

Manufacturing Engineering Medical IT 64

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. Many sponsors want to reduce animal testing and, therefore, welcome the approach. The main body of the draft guidance provides high-level recommendations, and four appendices provide detailed recommendations for test design.

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law Blog

SEPTEMBER 6, 2022

This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). Changes from the 2016 Guidance. Livornese — FDA recently published a Draft Guidance entitled “Charging for Investigational Drugs under an Investigational New Drug Application: Questions and Answers” (the Draft Guidance).

Clinic 52

Clinic Manufacturing Patients IT 52

FDA Law Blog

OCTOBER 5, 2022

The guidance also advised food manufacturers of FDA’s intent to exercise enforcement discretion for foods that are a good source of potassium, and vitamin D, as these two nutrients had been designated nutrients of public health concern in the 2016 final nutrition labeling regulation).

Provider 52

Provider Individual IT Manufacturing 52

FDA Law Blog

JANUARY 26, 2022

Note that Allysa Seely is a Paralympian gold medal triathlete, and swimmer Ryan Murphy is a 2016 Olympian and gold medalist.) By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming!

IT 40

IT Education Utilities Patient-Centered 40

FDA Law Blog

OCTOBER 20, 2021

As we have previously discussed , under the PMTA pathway, manufacturers must demonstrate that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. In a press release announcing the orders, Mitch Zeller, J.D., million products, mostly ENDS products, by the deadline of Sept.

Electronics 52

Electronics Provider Manufacturing IT 52

FDA Law Blog

APRIL 19, 2021

The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug. Two judges on the D.C.

Manufacturing 40

Manufacturing Government Medical IT 40

FDA Law Blog

APRIL 11, 2022

As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. During an inspection, FDA learned that Medtronic had opened a CAPA to address complaints of damaged retainer rings in these pumps (more than 74,000 between June 2016 and November 2019, with more than 57,000 reported to FDA as MDRs).

Medical 40

Medical Management Manufacturing Patients 40

FDA Law Blog

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The statute achieves this through disclosure of information by the software manufacturer about the “basis for” the recommendations made by the software.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law Blog

SEPTEMBER 5, 2023

Legitimate handlers in the cultivation, manufacturing and distribution chain would have to obtain registrations with DEA. DEA and HHS last considered rescheduling cannabis in 2016. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. 53,688 (Aug. 53,767 (Aug. 21 U.S.C. § at 53,689, 53,768.

Medical 111

Medical IT Manufacturing Utilities 111

FDA Law Blog

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. In that letter, FDA stated that it would “permit manufacturers. October 31. October 1 – December 31.

Medical 59

Medical Manufacturing Individual Provider 59

FDA Law Blog

JANUARY 18, 2024

FDA conducted the eight-factor scheduling analysis required by the CSA in 2016 and found that marijuana continued to meet the scheduling criteria for remaining in schedule I. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

Medical 69

Medical Physicals IT Healthcare Professional 69

FDA Law Blog

MAY 5, 2024

FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. 29, 2023). Letter to U.S. and lack accepted safety for use under medical supervision.

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95

FDA Law Blog

JUNE 24, 2021

In 2016, FDA opened a docket seeking comments on “service, maintenance, refurbishment, and alteration of medical devices” by third parties (see our blog post here ). In contrast, a device servicer is not a device manufacturer and, therefore, need not comply with the QSR.

Manufacturing 52

Manufacturing Medical Provider IT 52

FDA Law Blog

JUNE 12, 2022

Back in 2016, the First Circuit’s decision in United States ex rel. 2016) , was seen as a death knell for the fraud?on-the-FDA By Jeffrey K. Shapiro & Anne K. Walsh — Legal doctrines can be like parrots. Sometimes it is hard to know if they are dead or just resting. This fraudulent inducement theory is well? D’Agostino v.

IT 52

IT Manufacturing Government 52

FDA Law Blog

FEBRUARY 4, 2025

The authors suggested that the developers of such therapies would receive a priority review voucher that they can sell to manufacturers of blockbuster drugs. This time, however, the program, which has helped incentivize the development of dozens of pediatric rare disease therapies since 2012, was not renewed.

IT 52

IT Vaccination Manufacturing Medical 52

FDA Law Blog

APRIL 7, 2025

Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. The detail with which CVM reviewed these promotions is reminiscent of OPDP/DDMAC letters of yore.

Vaccination 64

Vaccination IT Manufacturing Screening 64

FDA Law Blog

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

Physicals 69

Physicals Medical Clinic Emergency Room 69

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. H5N1 is currently known to be widespread among wild birds and is thought to be spread by migratory waterfowl.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

FDA Law Blog

AUGUST 10, 2021

The idea of basing Medicare drug reimbursement on prices in foreign countries was first proposed during the Obama Administration in 2016. Use of international reference pricing as a target for Medicare to negotiate prices with drug manufacturers appears in H.R. The Trump Administration rule had a troubled history. 3 , the “Elijah E.

Finance 52

Finance Insurance Manufacturing IT 52

FDA Law Blog

SEPTEMBER 14, 2021

The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed.

Manufacturing 52

Manufacturing Insurance Government Patients 52

FDA Law Blog

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

FDA Law Blog

MAY 19, 2022

By Faraz Siddiqui — Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. On Tuesday, May 17, 2022, the D.C.

Manufacturing 40

Manufacturing Patients Insurance Government 40

FDA Law Blog

NOVEMBER 8, 2022

For whose manufacturers who do not intend to continue device distribution, FDA generally does not intend to request market removal of those devices distributed before the applicable EUA termination or guidance withdrawal date. CDRH’s pandemic responses included more than 4,000 medical devices authorized.

Medical 59

Medical Manufacturing Patient-Centered Provider 59

FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate. Last Thursday, the U.S.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98