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…this brief provides the clearest statement of FDA’s limited authority to compel a recall. We previously described (here and here) the litigation commenced by Hospira, Inc. (“Hospira”) wherein the company…
…are living longer and facing the ailments so common to old age. Enter the FDA’s Center for Veterinary Medicine (“CVM”). A longstanding component of the FDA and its predecessor, CVM,…
…it is both unnecessary and futile to dissuade dogs from consuming them. Intake by humans appears more selective, but those in the know are strong advocates. Globally, the United Nations…
…violations of the Prop. 65 warning requirement related to acrylamide in food products. Companies trying to avoid the cost of defending actions and penalties, as well as costly and complicated…
…device in tissues of interest in humans or an appropriate animal model should be provided. While histological data is common in studies of animal models, it is not clear how…
…not be held in contempt, for failure to comply with the Court’s 2004 order that permanently enjoined DEA from regulating hemp fiber, stalk, sterilized seed and oil as controlled substances….
…FDA seeking declaratory judgment and injunctive relief with regard to FDA’s detention of two entries of semi-purified heparin. According to the Complaint, the entries, proposed for import in May 2010…
…Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide – This much shorter…
…indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals.” The relative difficulty of meeting the current standard, coupled with…
…questioned the facility’s decision to release certain products into commerce: Your facility distributed at least a portion of eight (8) lots of peanut and almond butter… after composite testing of…
…by FDA. . . . The GPhA fully supports an expedited communication process through which FDA can notify both generic and brand-name drug companies, as well as healthcare practitioners of…
…not over, as FDA has filed a petition for panel rehearing and rehearing en banc of the D.C. Circuit’s March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius,…
…at FDA or by assisting companies develop product development strategy or navigate the regulatory process. Strong verbal and writing skills are required. Compensation is competitive and commensurate with experience. HP&M…
…kindly promoted FDA Law Blog. We look forward to the continuing success of FDA Law Blog. We encourage you to email us (jwasserstein@hpm.com or kkarst@hpm.com) with your comments and suggestions….
…patents as to which the applicant submitted a certification qualifying it for the 180-day exclusivity period have expired.” FDA issued its response after soliciting public comment on whether Teva forfeited…