Drugs
A new study published online in JAMA finds that pharmaceutical companies often conducted clinical trials after winning FDA approval, but most were not related to the approved use unless directed by the agency in a postmarketing requirement or commitment at initial approval. The study, conducted by researchers at Tufts School
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Considerations in Demonstrating Interchangeability With a Reference Product.” The document focuses on therapeutic protein products and gives an overview of important scientific considerations in demonstrating interchangeability of a proposed therapeutic protein product with a reference product. To view the
Devices
FDA has cleared a Haemonetics 510(k) to expand the medical indication of its TEG 6s Hemostasis Analyzer System for use in adult trauma settings. This clearance builds on the current indication for the TEG 6s system in cardiovascular surgery and cardiology procedures. Clearance was based on clinical data from
Drugs
A 10/15-11/1/18 FDA inspection at Bershtel Enterprises, Duarte, CA, found violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 5/2 Warning Letter says specific inspection observations were: * failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug
Drugs
In a unanimous decision, the Supreme Court has said that whistleblowers will have up to four years of additional time to file False Claims Act (FCA) suits against healthcare and other firms. The justices said that FCA claimants can sue up to three years after the responsible federal official knew
Drugs
FDA has approved Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat all stages of diabetic retinopathy. Approval was based on data from the PANORAMA trial which showed that “20% of untreated patients developed proliferative diabetic eye disease, and Eylea reduced this risk by 85% to 88% when administered using an every
Drugs
Connecticut attorney general William Tong has led a 44-state lawsuit against Teva Pharmaceuticals and 19 generic drug manufacturers that alleges a “broad conspiracy to artificially inflate and manipulate prices, reduce competition and unreasonably restrain trade for more than 100 different generic drugs.” The lawsuit, filed in Connecticut federal court,
Devices
FDA has approved Abiomed’s expanded use of its Impella 5.0 and Impella LD heart pumps for treating cardiogenic shock. The expansion extends the duration of support for each pump from six days to 14 days. The forward flow heart pumps are intended for stabilizing a patient’s hemodynamics,
Drugs
For the second time in a week, FDA finds itself defending its medical product oversight after a New York Times opinion piece questions the safety and quality of the products. Last week, the paper’s editorial board published a scathing critique of medical device regulatory oversight, urging FDA to abolish
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for W.L. Gore & Associates’ Gore Viabahn VBX Balloon Expandable Endoprosthesis is 1,136 days, which includes 931 days that occurred during the testing and 205 days during the approval phase. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 6/7 public meeting entitled “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” The meeting is intended to review performance commitments included in the user fee agreements. It will also
Drugs
FDA reviewers are questioning the robustness of data submitted in a Daiichi-Sankyo NDA for quizartinib, indicated for treating adults with relapsed or refractory acute myeloid leukemia (AML) which is FLT3-ITD positive, as detected by an FDA-approved test. In a briefing document released before a 5/14 Oncologic
Devices
FDA has cleared a Zebra Medical Vision 510(k) for the HealthPNX, an artificial intelligence (AI) alert for pneumothorax, based on chest x-rays. Pneumothorax is a condition in which there is an accumulation of gas within the pleural space between the lung and the chest wall. Without prompt attention,
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for Auspex Pharmaceuticals’s Austedo (deutetrabenazine), indicated for treating chorea associated with Huntington’s disease, is 1,736 days, which includes 1,060 days that occurred during the testing phase and 676 days during the approval phase. To view
FDA Policy/General
Guide on Submitting ANDA or 505(b)(2) NDA Federal Register notice: FDA makes available a guidance entitled “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” 05/10/2019 Topical Active Ingredients for OTC Monograph Guide Federal Register notice: FDA makes available a final guidance entitled
FDA Policy/General
BIOLOGICS FDA has approved The Medicines Company’s Raplixa and RaplixaSpray low-pressure spray applicator to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical. The company says the
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” The document highlights criteria for submitting applications under the abbreviated approval pathways described in Section 505(j) and 505(b)(2), identifies considerations to help potential applicants determine
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.” The document discusses the conduct of in vivo absorption trials for topically applied active ingredients that are
Drugs
FDA has released a final guidance entitled “Considerations in Demonstrating Interchangeability With a Reference Product” to help sponsors navigate the pathway for “interchangeable” biologics/biosimilars, which may be substituted without prescriber involvement. Although the 351(k) biosimilar pathway applies generally to biological products, the guidance focuses on therapeutic protein products
Drugs
The quality of the U.S. drug supply is the best it has ever been, says CDER Office of Pharmaceutical Quality director Michael Kopcha. This FDA assurance comes on the heels of a 5/10 CBS News report about allegations of widespread fraud associated with generic drugs made overseas and
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations.” The document is mainly focused on reproductive toxicity (embryo-fetal development), and it provides recommendations to applicants for pharmaceutical labeling on duration of contraception following therapy cessation to minimize potential risk
Devices
Reps Rosa DeLauro (D-CT), Jan Schakowsky (D-IL), and Brian Fitzpatrick (R-PA) have reintroduced the Medical Device Safety Act, a bill to increase access to legal recourse for victims of unsafe devices. The bill comes on the heels of a New York Times editorial on changes FDA should