Drugs
FDA has issued a draft guidance, Standardization of Data and Documentation Practices for Product Tracing, elaborating standards for the interoperable exchange of transaction information, transaction history, and transaction statements required by the Drug Supply Chain Security Act to facilitate tracing products through the pharmaceutical distribution supply chain by requiring trading
Drugs
FDA has accepted a Shire BLA for calaspargase pegol (Cal-PEG; SHP663), indicated as a component of a multi-agent chemotherapeutic regimen for treating patients with acute lymphoblastic leukemia. The agency has set a user fee review action target date of 12/22. The mechanism of action is thought to
Devices
FDA has approved a Medtronic PMA supplement for a new arm indication for the Guardian Sensor 3 glucose monitor that will enable patients to wear the sensor on the upper arm. The company says this is the only sensor FDA approved to control automated insulin delivery via a hybrid closed
Drugs
FDA has approved a Scilex Pharmaceuticals NDA for ZTlido (lidocaine topical system) 1.8%, indicated for relieving pain associated with post-herpetic neuralgia (post-shingles pain). The anhydrous topical system is based on a novel technology that is designed to achieve superior adhesion and drug delivery efficiency, according to the
Devices
CDRH director of Ophthalmic, and Ear, Nose, and Throat Devices Malvina Eydelman says that since passage of the 21st Century Cures Act, CDRH has received 94 requests for breakthrough devices treating a variety of conditions, and has granted 54 of them. Writing in an FDA Voice blog post, Eydelman says
FDA Policy/General
Federal Register notice: FDA has announced a 3/29-30 Clinical Chemistry and Clinical Toxicology Devices Panel meeting. On 3/29, the committee will discuss and vote on a Senseonics PMA for the Eversense CGM System, a continuous glucose monitoring device. On 3/30, the committee will discuss measuring blood
Drugs
FDA has posted an International Council for Harmonization guidance on “E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1)” that provides a unified standard for regulatory agencies to allow the mutual acceptance of clinical data. The document amends earlier guidance to encourage implementation of improved and more efficient
Drugs
FDA has issued Celgene a refusal-to-file letter on an NDA for ozanimod for treating patients with relapsing forms of multiple sclerosis. In the letter, the agency said its preliminary review determined that the nonclinical and clinical pharmacology sections in the submission were insufficient to permit a complete review,
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension for “Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development” (OMB Control Number 0910-0787). The information collection supports agency guidance on staff meetings with
Drugs
Attorney Kurt Karst (Hyman, Phelps & McNamara) says FDA granted 476 orphan drug designation requests in 2017 and approved 77 orphan drugs. He says requests for designation and approvals both “skyrocketed” last year, “obliterating” the previous records of 49 approvals in 2014 and 355 requests in 2015. “The increase in
Drugs
The former president of Cumberland Distribution, Inc., a Houston, Texas-based drug company, was convicted by a Tennessee federal court jury of conspiracy, 15 counts of mail fraud, and one count of making false statements to FDA in connection with a 32-month, $50 million drug diversion scheme. An FDA
Drugs
The FDA Office of Pharmaceutical Quality (OPQ) 2017 annual report outlines challenges faced by the organization last year and the key quality initiatives it undertook. OPQ director Michael Kopcha says the challenges included new commitments in conjunction with reauthorization of human drug user fee programs and the devastation caused by
Drugs
The Justice Department (DoJ) says it will file a “Statement of Interest” in a multi-district action regarding hundreds of lawsuits against opioid manufacturers and distributors. Plaintiffs in the suits include numerous cities, municipalities, and medical institutions that have borne the costs of the prescription opioid crisis. They contend the
Drugs
A 9/11-9/15/17 FDA inspection at Alchymars ICM SM Private Limited, Chennai, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to a 2/16 Warning Letter. Specific deviations cited in the letter were: * failing to have laboratory control records
FDA Policy/General
Federal Register notice: FDA has classified Lynch syndrome test systems into Class 2 (special controls). The action is based on a Ventana Medical Systems de novo classification request for its Ventana MMR IHC Panel. The agency has named the generic device as Lynch syndrome test systems, which are identified as
FDA Policy/General
Federal Register notice: FDA has corrected a 6/21/2017 Federal Register notice that announced the withdrawal of approval of 121 NDAs and 161 ANDAs from multiple applicants. A Baxter Healthcare NDA for Clinolipid 20% (olive oil and soybean oil) USP that was included in the original notice is now
FDA Policy/General
Federal Register notice: FDA has announced a 5/9 public workshop on “Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation.” The workshop is intended to discuss factors the agency should consider when evaluating drugs for orphan designation that treat a tissue-agnostic disease or condition in oncology,
Drugs
A 4/10-4/14/17 FDA inspection at Shanghai Weierya Daily Chemicals Factory, Shanghai, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/7 Warning Letter. Specific violations cited in the letter were: * failing to have for each batch of
FDA Policy/General
Healthcare and legal researchers at Harvard Medical School and the Georgia State University College of Law say the proposed Regulatory Accountability Act of 2017 “could have potentially disastrous consequences for FDA and other agencies that protect public health.” Writing in the New England Journal of Medicine, the authors say (subscription
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Alchymars ICM SM Private Ltd. Chennai, India (2/16): FDA inspected the firm 9/2017 and cited significant GMP deviations for active pharmaceutical ingredients. For example, the firm failed
Drugs
Akorn says it and Fresenius are using outside consultants to investigate alleged breaches of FDA data integrity requirements relating to product development at Akorn. “To date the company’s investigation has not found any facts that would result in a material impact on Akorn’s operations and the company does
Devices
FDA has cleared an Acclarent 510(k) to expand the indication for the Acclarent Aera Eustachian Tube Balloon Dilation System to include its use in patients as young as 18. The device was previously cleared only for adults aged 22 and older. In addition, the company says recent evidence shows