November 27, 2018 marked five years since President Obama signed the Drug Quality and Security Act (DQSA) into law. The law addresses two distinct areas of drug oversight, but it was the combined concerns about the quality...more
• FDA has put out a new draft MOU for stakeholders to review and provide comments over the next 90 days.
• If a state enters into the proposed MOU, pharmacies within its borders would be allowed to distribute up to 50...more
• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted.
• Many of the more dramatic proposals would require federal rulemaking or...more
5/17/2018
/ Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Patients ,
Pharmaceutical Industry ,
Prescription Drugs ,
Request For Information ,
Section 340B ,
Trade Agreements ,
Trump Administration ,
WTO
• The new national Medicare coverage determination covers only FDA-authorized NGS tests with companion diagnostic indications, leaving NGS cancer tests without that specific indication to seek coverage from local Medicare...more
4/3/2018
/ American Medical Association ,
Cancer ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coding ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Laboratories ,
Marketing Authorization Application ,
Medicare ,
Medicare Part B ,
PAMA ,
Payment Rates ,
Personalized Medicine ,
Physician Medicare Reimbursements
Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration...more
• Two new draft guidances aim to conform FDA’s existing digital health-related policies to the software exemptions from the device definition added by Cures, and are largely faithful to those legislative provisions.
• The...more
1/3/2018
/ 21st Century Cures Act ,
Center for Drug Evaluation and Research (CDER) ,
Digital Health ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Device User Fee Program (MDUFA IV) ,
Medical Devices ,
Medical Software ,
Regulatory Requirements ,
Software Developers ,
Technology Sector
A Food and Drug Administration (FDA) inspector has just knocked on your door and announced that he or she will now inspect your facility. What happens before, during and after this inspection, and what should your firm do to...more
9/12/2017
/ Beverage Manufacturers ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FDA Reauthorization Act ,
Food and Drug Administration (FDA) ,
Food Safety ,
FSMA ,
Information Requests ,
Inspections ,
Medical Devices ,
Office of Regulatory Affairs (ORA) ,
Prescription Drugs
The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more
Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more
8/9/2017
/ Biologics ,
Biosimilars ,
BsUFA ,
Diagnostic Imaging Services ,
Drug Pricing ,
FDA Reauthorization Act ,
FDARA ,
Food and Drug Administration (FDA) ,
GAO ,
GDUFA ,
Generic Drugs ,
Legislative Riders ,
Medical Device User Fee Program (MDUFA IV) ,
Medical Devices ,
National Evaluation System for Health Technology (NEST) ,
Over-the-Counter Sales ,
PDUFA ,
Pediatrics ,
Pending Legislation ,
Prescription Drugs ,
Supply Chain ,
User Fees
Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more
Key Points -
- Although the Cures medical software provisions largely align with FDA's current policies, certain of the Cures exemptions may be broader than those under current agency policy.
- Many clinical...more
Key Points -
- The 21st Century Cures Act (“Cures” or the “Act”) significantly impacts FDA’s review and approval of medical devices, and how medical devices are covered and paid for.
- These new authorities...more
If you read one thing...
- FDA interprets the FDCA not to permit compounding for “office use” under Section 503A; compounding pharmacies must receive a valid prescription for an individually identified patient before...more
If you read one thing...
- FDA released Draft Guidance outlining steps for medical device manufacturers to ensure cybersecurity of medical devices already on the market; comments are due by April 21, 2016.
-...more
The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more
2/20/2015
/ Biologics ,
DQSA ,
Draft Guidance ,
Drug Compounding ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Outsourcing ,
Pharmaceutical Industry ,
Pharmacies ,
Premarket Approval Applications ,
Prescription Drugs
Draft Guidances Address General Wellness Products and Device Accessories -
The U.S. Food and Drug Administration (FDA or “the Agency”) has announced two more key parameters of its regulatory approach to mobile health...more
FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more
On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more
On July 31, the Food and Drug Administration (FDA or “the Agency”) notified Congress that it intends to issue draft guidance proposing a Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (“Draft...more
July 24, 2014 was a landmark day in the biotechnology industry: Sandoz (the generic arm of Novartis) announced that the U.S. Food and Drug Administration (FDA or “the Agency”) had accepted the first application for a U.S....more
In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more