FDA Policy/General
Federal Register Notice: FDA is asking for comments on a submission to OMB seeking to extend an information collection related to a guidance on “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.” The document offers recommendations on the content and format of such letters sent by manufacturers
FDA Policy/General
Federal Register Notice: FDA is asking for comments on a submission to OMB seeking to extend an information collection related to CDRH’s Pre-Submission Program for Medical Devices. Under the program, FDA provides recommendations on the information that should be submitted in a Pre-Submission package and procedures that
FDA Policy/General
Federal Register Notice: FDA is seeking public comments on emerging issues and cross-cutting scientific advances that may impact FDA preparedness and inter-agency activities. “Emerging sciences, such as synthetic biology, are expected to impact FDA regulated products in the relatively near term,” the agency says. In response, the agency
FDA Policy/General
A Hillary Clinton presidential campaign hacked email released by Wikileaks shows how former president Bill Clinton and other top Democrats lobbied Biogen and FDA to gain a compassionate use exemption for Tysabri (natalizumab) and its use in a dying top donor, Fred Barron. At the time (2008), the drug was
FDA Policy/General
Federal Register Notice: FDA is seeking comments on extending a collection of information on requirements for medical device PMA submissions. The requirements also cover recordkeeping and maintenance of records. For example, records used to trace patients and the organization and indexing of records into identifiable files to ensure the device’
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Amgen’s Repatha (evolocumab) for patent extension purposes. The agency has calculated the regulatory review period as 2,267 days. Of this time, 1,901 days occurred during the testing phase of the regulatory review. To view this notice,
FDA Policy/General
A 5/2-6/3 FDA inspection at Vetix, Lexington, KY, found multiple violations in the firm’s distribution of animal drug products, according to a 10/12 Warning Letter from the agency’s Cincinnati District Office. Specific concerns on an FDA-483 included: * distributing unapproved new animal drugs — OptiMend,
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Eagle Pharmacy, Inc. Hoover, AL (10/13). FDA investigator inspected the firm’s drug compounding operations 8/2015 and documented serious deficiencies in its practices for producing sterile drug
FDA Policy/General
Federal Register Notice: FDA has proposed to withdraw ANDA approval for methylphenidate hydrochloride extended-release tablets, and is announcing an opportunity for the holder of the ANDA, Kremers Urban Pharmaceuticals, to request a hearing. After receiving adverse event reports, FDA determined there was an insufficient therapeutic effect of the Kremers
FDA Policy/General
Federal Register Notice: FDA has proposed to withdraw ANDA approval for methylphenidate hydrochloride extended-release tablets, and is announcing an opportunity for the holder of the ANDA, Mallinckrodt Pharmaceuticals, to request a hearing. After receiving adverse event reports, FDA determined there was an insufficient therapeutic effect of the Mallinckrodt’s
FDA Policy/General
Federal Register Notice: FDA has proposed to amend its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe. Drugs appearing on this list may not be
FDA Policy/General
Federal Register Final Order: FDA has classified as Class 2 (special controls) the upper extremity prosthesis including a simultaneously powered elbow and shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components. The special controls will be part of the codified language for
FDA Policy/General
Federal Register proposed rule: FDA has proposed to implement provisions requiring electronic submission of the device label and package insert of certain home-use devices when these devices are listed with the agency. FDA also plans to make this device labeling available to the public through the Internet and would
FDA Policy/General
Federal Register Final Order: FDA has classified the apical closure device into Class 2 (special controls). The controls will be part of the codified language for the device’s classification. To view this order, click here.
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “ANDA Submissions — Prior Approval Supplements Under GDUFA.” The document is intended to assist applicants preparing to submit prior approval supplements and amendments to prior supplements. It also describes FDA’s performance metric goals for such supplements. To view this guidance,
FDA Policy/General
Federal Register Notice: FDA and Johns Hopkins University Center of Excellence in Regulatory Science and Innovation have announced a 11/18 public workshop on “Substitutability of Generic Drugs: Perceptions and Reality” to discuss agency and industry practices related to generic drug postmarket surveillance, research activities, public perceptions on generic drug
FDA Policy/General
Federal Register Notice: FDA has issued a priority review voucher to Sarepta Therapeutics after determining its NDA for Duchenne muscular dystrophy drug Exondys 51 (eteplirsen) met criteria as a rare pediatric disease product. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has announced the renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/7/2018. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has renewed the Antimicrobial Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/7/2018. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance on “Software as a Medical Device (SaMD): Clinical Evaluation.” The document was prepared under the auspices of the International Medical Device Regulators Forum, formerly the Global Harmonization Task Force. It focuses on the general principles of clinical evaluation, which includes
FDA Policy/General
FDA acting associate commissioner for special medical programs Janice Soreth, who is now chairing the FDA Safety and Innovation Act (FDASIA) Section 907 steering committee to increase clinical trial diversity, says progress has been made on nearly all of the action items the agency needed to take. Writing in an
FDA Policy/General
Federal Register Final Rule: FDA has amended its regulations on the definition of a custom device to include new enumerated statutory requirements for such products. It amends the existing custom device exemption and introduces new concepts and procedures applicable to them. The amended definition states that a device will qualify