FDA Policy/General
Federal Register notice: FDA has announced a 4/23 g Arthritis Advisory Committee meeting. Panel members are scheduled to discuss an Eli Lilly NDA for baricitinib tablets, indicated for treating adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “MedWatch: The FDA Medical Products Reporting Program” (OMB Control Number 0910-0291). MedWatch permits the reporting of adverse events, product problems, errors with the use of a human medical product, and evidence of therapeutic failure in clinical
FDA Policy/General
Federal Register notice: FDA has amended a 1/23 notice about a 3/22 Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee meeting to reflect a change in the agenda for the open session of the meeting and to extend the amount of time allotted for the closed
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed collection of information — “Health Care Professional Survey of Professional Prescription Drug Promotion.” The study will examine how health care professionals experience and perceive prescription drug promotion directed to them. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued an order exempting from premarket notification 510(k) requirements over-the-counter denture repair kits (product code EBO). The devices comprise material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to
FDA Policy/General
Federal Register correction notice: FDA is correcting a final order entitled “Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test Systems” that appeared in the 2/27 Federal Register. The document was published with the incorrect docket number, and is now corrected to read “FDA–2018–N–0399.
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of four Sun Pharmaceutical ANDAs because the drug products are no longer marketed. Affected generic products include enalapril maleate tablets, lorazepam tablets, zolpidem tartrate tablets, and zoledronic acid for injection. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 4/17 public meeting entitled “Patient-Focused Drug Development on Opioid Use Disorder.” The meeting will obtain patients’ perspectives on the impacts of and treatment approaches for opioid use disorder. It is part of FDA’s ongoing work aimed at reducing the impact
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Dexcowin Co. Seoul, Korea (2/20): FDA inspected the firm 8/2017 and cited GMP deficiencies with manufactured portable dental diagnostic X-ray devices. For example, the firm failed
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “M7(R1): Assessment and Control of Deoxyribonucleic Acid (DNA) Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.” The International Council for Harmonization document updates and replaces a 5/2015 guidance under the same title. The new guidance provides
FDA Policy/General
Federal Register notice: FDA has submitted to OMB for approval a new proposed information collection for a drug direct-to-consumer (DTC) broadcast advertising study entitled “Utilization of Adequate Provision Among Low to Non-Internet Users.” The primary focus will concern the ability and willingness of low to non-Internet
Drugs
FDA has announced new research to be conducted on direct-to-consumer (DTC) ads — “Utilization of Adequate Provision Among Low to Non-Internet Users.” Agency regulations require that broadcast advertisements contain a brief summary of side effects and contraindications or that “adequate provision” be made for dissemination of the approved
FDA Policy/General
Doryx Not Withdrawn Due to Safety/Effectiveness: FDA Federal Register notice: FDA determines that Mayne Pharma International’s Doryx MPC (doxycycline hyclate), delayed-release tablets, 60 mg, were not withdrawn from sale for safety or effectiveness reasons. 03/09/2018 Advisory Committee Docket Number Corrected Federal Register notice correction: FDA
FDA Policy/General
Biogen has agreed to purchase Pfizer’s PF-04958242, a first-in-class, Phase 2b-ready drug being evaluating to treat several neurological and psychiatric diseases, including schizophrenia. Biogen is paying $75 million upfront for the compound, and the agreement could include up to $515 million in developmental and commercial
FDA Policy/General
Federal Register notice: FDA has determined that Mayne Pharma International’s Doryx MPC (doxycycline hyclate), delayed-release tablets, 60 mg, were not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference Doryx if all other legal and regulatory requirements are met.
FDA Policy/General
Federal Register notice correction: FDA is correcting a 2/22 notice entitled “Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting.” The document was published with the incorrect docket number. The docket number is corrected to read “FDA-2018-N-0410.” To view the notice, click here.
FDA Policy/General
Sen. Tom Cotton (R-AR) and three Republican and Democrat colleagues have introduced the Preserve Access to Cost Effective Drugs (PACED) Act to restore the power of the Patent and Trade Office and federal courts and the International Trade Commission to review patents regardless of sovereign immunity claims made as
FDA Policy/General
Federal Register notice: FDA has classified the extracorporeal shock wave device for treating chronic wounds into Class 2 (special controls). The action is in response to a 7/2016 Sanuwave, Inc. de novo classification request for its dermaPace System. The agency has codified the device classification by adding 21 CFR
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection for “Reclassification Petitions for Medical Devices — 21 CFR Section 860.123” (OMB Control Number 0910-0138). Reclassification provisions of the Food, Drug & Cosmetic Act allow any person to petition for reclassification of a device from any of the
FDA Policy/General
Yale University researchers say their review of 97 unique direct-to-consumer (DTC) drug ads for 60 unique drugs found that few of the ads complied with FDA regulations. “The overall quality of information presented in ads was low, and suggestions of off-label promotions were common for diabetes medications,
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Nan San (HK) Pharmaceutical Factory Ltd., Hong Kong (2/23): FDA inspected the firm 9/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.” It is intended to describe the agency’s interpretation of terms used in the definitions of “suspect product” and “illegitimate product” in