Devices
CDRH has approved an alternative standard for using a quality assurance program recommended by the ACR Digital Mammography Quality Control Manual for full-field digital mammography systems. An agency notice says the alternative standard was approved and became effective 2/17, and it can be used by mammography facilities instead
Drugs
Bristol-Myers Squibb and LabCentral, a Cambridge, MA shared space and launch pad for life-sciences and biotech startups, have entered into an agreement under which Bristol-Myers Squibb has become a platinum sponsor and can nominate up to two startup companies per year to take up residence in the
Drugs
Six public health groups and pharmaceutical industry associations 2/7 sent House and Senate appropriators a letter urging lawmakers “to support strong federal oversight of drug compounding” and tougher FDA enforcement to protect patients from adulterated compounded products. “Language that impedes FDA’s ability to enforce compounding law, including prescription
Drugs
FDA needs to modernize preclinical tests to improve patient safety, according to Physicians Committee for Responsible Medicine senior science policy specialist for toxicology and regulatory testing Elizabeth Baker. Writing in a the Hill blog posting, Baker noted that patient deaths halted at least two pharmaceutical clinical trials in the last
Devices
In a 3/7 email copied to more than 200 FDA leaders, Capitol Hill figures and news media, 792 women told CDRH chief scientist and deputy director William Maisel they are demanding his resignation because they “are outraged that you still believe that Essure is an important, safe, and effective
Drugs
Sen. Al Franken (D-MN) has introduced legislation to end prescription drug advertising tax deductions. “Right now, pharmaceutical companies spend billions of dollars every year on television, magazine, and Internet advertisements - and the federal government gives those companies a tax break every time you see a drug advertisement,” a Franken
FDA Policy/General
Federal Register Final rule: FDA is amending the standing advisory committees regulations to change the name of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to the Pharmaceutical Science and Clinical Pharmacology Advisory Committee to more accurately describe the subject areas for which the committee is responsible. The name
Drugs
New York has reached an agreement with Endo Pharmaceuticals over its marketing of long-acting opioid, Opana ER. The agreement requires Endo to “cease all misrepresentations regarding the properties of Opana ER, to describe accurately the risk of addiction to Opana ER, and to summarize studies regarding Opana ER on
FDA Policy/General
BIOLOGICS FDA Proposes Blood Establishment Software into Class 2 Federal Register Proposed rule: FDA is proposing to classify the blood establishment computer software (BECS) and BECS accessories into Class 2 (special controls). The agency is also giving notice that the it does not intend to exempt BECS and BECS accessories
FDA Policy/General
Federal Register Notice: CDER is establishing a public docket to collect comments on a proposed Nonclinical Study Data Reviewer's Guide (SDRG) template. As part of FDA’s ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non-profit consortium addressing computational science issues, a PhUSE working
FDA Policy/General
Federal Register Notice: FDA’s collection of information entitled “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products'' has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view
FDA Policy/General
As most modern FDA commissioners before him did (but more gradually), Robert Califf has swiftly embraced support and defense of the agency workforce below him as Job One. His time as one of them for the past year before his Senate confirmation last week no doubt gave him a major
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization. It addresses the inclusion of a boxed warning and a patient decision checklist in the product labeling for the implants and the content and format of those materials. This
FDA Policy/General
Federal Register Notice: FDA is establishing a docket to receive information and comments on the medical device industry and healthcare community that refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices including radiation-emitting devices subject to the electronic product radiation control provisions of FD&C Act. To
FDA Policy/General
Federal Register Final rule: FDA is amending the Unique Device Identification (UDI) System regulation to make editorial changes. FDA is updating the UDI email address to [email protected] in the following regulations that set forth the procedures for notifying the agency when: (1) Requesting an exception from or
Devices
FDA has posted a draft guidance on “Clinical Considerations for Investigational Device Exemption (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes” to assist sponsors in evaluating the benefits and risks of devices that target either the cause or progression of a neurological disorder or condition such as Alzheimer’
Drugs
FDA has released a guidance on “Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity” that addresses specific considerations for drugs that have potential estrogenic, androgenic, or thyroid hormone pathway activity in the environment. FDA says the document is intended to help sponsors of such drugs
Drugs
New York has reached an agreement with Endo Pharmaceuticals over its marketing of long-acting opioid, Opana ER. The agreement requires Endo to “cease all misrepresentations regarding the properties of Opana ER, to describe accurately the risk of addiction to Opana ER, and to summarize studies regarding Opana ER on
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Medical Device User Fee Small Business Qualification and Certification,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
Devices
FDA has cleared a Stryker Spine 510(k) for its Tritanium PL Posterior Lumbar Cage, an intervertebral body fusion device that aids in lumbar spinal fixation for patients with degenerative disc disease. The device is constructed out of proprietary Tritanium technology and is manufactured using a 3D additive manufacturing process.
Devices
FDA has posted a guidance on “Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails” that provides recommendations on clinical trial designs for devices intended either (1) to provide improvement in the appearance of nails affected by onychomycosis; or (2) to
Drugs
The Pew Charitable Trusts has issued a question-and-answer paper on biologics and biosimilars. The paper says that biosimilars “present unique challenges to policymakers looking to control healthcare costs while providing patients with needed medications.” Questions presented in the paper are: How do biologic drugs differ from conventional pharmaceuticals?