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Focus on Regulation

Tag Archives: drugs and biologics

21st Century Cures Offers More Latitude to Promote Health Care Economic Information, but Ambiguities Would Remain

Last Wednesday, the U.S. House of Representatives passed the 21st Century Cures Act , the culmination of an extensive, multi-year effort by the House Energy and Commerce Committee to develop this sweeping legislation. The 21st Century Cures Act now faces a vote in the Senate, likely within days.  The White House has already expressed support for

New Rule Amends FDA’s Citizen Petition Regulations to Implement Section 505(q) of the Food, Drug, and Cosmetic Act

The U.S. Food and Drug Administration (FDA) has issued a final rule implementing section 505(q) of the Federal Food, Drug, and Cosmetic Act (FDCA).  Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets, 81 FR 78500 (Nov. 8, 2016). Congress enacted 505(q) with the purpose of ensuring that

Let’s Get Real: Meredith Manning Urges FDA to Allow Greater Communication of Real World Data Within Its Current Regulatory Framework

On October 26, 2016, Hogan Lovells partner Meredith Manning submitted a comment to the U.S. Food and Drug Administration (FDA) urging the agency to allow the use of observational data in manufacturers’ advertising and promotion of drugs and medical devices. The FDA is holding a public meeting  on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared

FDA Publishes Draft Guidances and Memorandum of Understanding on Drug Compounding and Repackaging

On February 13, 2015, FDA issued four draft guidance documents and a draft memorandum of understanding (MOU) regarding the compounding of drug and biological products and the regulation of outsourcing facilities under the Drug Quality and Security Act (DQSA), enacted in November 2013.

Three of the guidance documents clarify the circumstances under which an entity should register as an outsourcing facility and the circumstances under which FDA expects to exercise enforcement discretion as to entities that repackage human prescription drug products or mix, dilute, or repackage biological products. The last guidance addresses adverse event reporting requirements for outsourcing facilities. The agency also published a draft MOU that may be used between a state and FDA concerning responsibilities for oversight of compounding activities.

Less is More in FDA’s Eyes: FDA’s Revised Draft Guidance on Disclosing Risk Information

On Monday, February 9, 2015, the Food and Drug Administration (FDA) published a revised draft guidance addressing disclosure of risk information requirements in direct-to-consumer (DTC) print advertising and promotional labeling for prescription drugs. It replaces the agency’s 2004 guidance, Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements and provides the agency’s current recommendations on how to best comply with the “brief summary” requirement.


On 22 January 2015, the Sixth Chamber of the General Court of the Court of Justice of the European Union (“General Court”) issued its judgment in Case T‑140/12 Teva Pharma and Teva Pharmaceuticals Europe v EMA concerning market exclusivity for orphan medicinal products. As part of the General Court’s judgment, the Court examined the possibility

FDA Issues New Guidance on cGMP for Combination Products

On January 23, 2015, FDA issued its long-awaited guidance document on current good manufacturing practice (cGMP) requirements for combination products. The guidance, entitled “Current Good Manufacturing Practice Requirements for Combination Products,” comes two years after FDA’s January 22, 2013 final rule established specific combination product cGMP regulations (codified in 21 CFR Part 4).

Taking Another Step Into Modern Healthcare: FDA Proposes Rule to Require Electronic Distribution of Prescribing Information for Human Prescription Drugs

Last month, the Food and Drug Administration (FDA) published a proposed rule, 79 Fed. Reg. 75506, requiring manufacturers to distribute prescribing information (PI) electronically—in lieu of paper copies—to satisfy the regulatory requirement that a prescription drug bear adequate instructions for use on or within the drug’s package. Traditionally, manufacturers have met this requirement by providing a copy of the PI printed on thin paper in small font, and folded in an origami-like fashion so that the PI can fit in the drug carton or be attached to the drug’s packaging.


The European Medicines Agency (“EMA”) has published its Guide on access to unpublished documents (the “Guide”).

In accordance with European Union (“EU”) law, any person may request access to unpublished documents held by the EMA. The Guide is intended to provide practical guidance concerning the process for requesting access to these documents. The new Guide is in the form of a Questions and Answers document and includes a flow chart of the access-to-documents process.

NIH Proposes Significant Expansions and Modifications to Requirements for Clinical Trial Registration and Results Disclosure on the ClinicalTrials.gov Data Bank

On Friday the National Institutes of Health (NIH) published an extensive proposed rule, intended to clarify and expand the requirements for submission of clinical trial registration and results information to the ClinicalTrials.gov data bank. See 79 Fed. Reg. 69,566 (Nov. 21, 2014). The rulemaking proposes to add a new Part 11 to Title 42 of the CFR to implement the statutory requirements set forth in section 402(j) of the Public Health Service Act (PHSA). Section 402(j) had been added to the statute by the Food and Drug Administration Amendments Act of 2007 (FDAAA).


On 1 October 2014 the European Medicines Agency (“EMA”) opened a consultation on revisions to its guideline on core summary of product characteristics (“SmPC”) for human plasma derived and recombinant coagulation factor IX products (the “Guidelines”).

The Guidelines are intended to provide harmonised guidance to applicants and regulators regarding the information that is to be included in the SmPC for human plasma derived and recombinant coagulation factor IX products, which are indicated for use in the treatment of prophylaxis of bleeding in patients with haemophilia B.

FDA Issues Revised Draft Guidance on Reporting Drug Sample Information Under the ACA

On July 11, FDA issued new draft guidance concerning drug sample reporting mandated under the Affordable Care Act (ACA).  The guidance, Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act, replaces agency’s earlier April 2012 guidance, Compliance Policy on Reporting Drug Sample Distribution Information.  In this new document, the agency provides more

OIG Issues Supplemental Special Advisory Bulletin Expanding Guidance on Independent Charity Patient Assistance Programs

Likely in response to recent controversy and public scrutiny, on 21 May 2014, the Office of Inspector General issued a supplemental Special Advisory Bulletin regarding independent charitable organizations that provide cost-sharing assistance for prescription drugs, including to federal healthcare program beneficiaries. Read More: OIG Issues Supplemental Special Advisory Bulletin Expanding Guidance on Independent Charity Patient

FDA Issues Proposed Rule to Implement Its New Authority to Destroy Drugs Valued at $2,500 or Less That Are Refused Import Into the U.S.

On May 6, 2014, FDA issued a proposed rule to implement the agency’s new administrative authority to destroy drugs valued at $2,500 or less that have been refused admission during importation into the United States1. FDA is requesting that interested parties submit comments on the proposed rule by July 7, 2014. FDA developed the proposed

Preliminary Code Decisions Issued by CMS

On April 9, 2012, the Centers for Medicare and Medicaid Services issued preliminary decisions on requests for a Healthcare Common Procedure Coding System (HCPCS) code effective January 1, 2013 for drugs and biologicals.  The preliminary decisions are available via the CMS website.  These decisions will be discussed at a public meeting to be held at